September 2002

Cataract Extraction Units,

Phacoemulsification
Phacoemulsification is widely used by ophthalmic
Scope of this Product Comparison surgeons because the entire procedure — cataract ex-
This Product Comparison covers phacoemulsifi- traction and implantation of an intraocular lens (IOL) —
cation systems with ultrasound (US), irrigation/ can be done through a single small incision that may help
aspiration (I/A), and anterior vitrectomy capabili- control or reduce surgically induced astigmatism,
ties. Units with only one of these capabilities are
excluded.
These devices are also called: phacoemul-
sifiers.

UMDNS information
This Product Comparison covers the following
device term and product code as listed in ECRI’s
Universal Medical Device Nomenclature Sys-
tem™ (UMDNS™):
• Cataract Extraction Units, Phacoemulsifica-
tion [17-596]

Purpose
Phacoemulsification systems are used to break up
and remove cataractous lenses of the eye. A cataract
forms when the normally transparent lens becomes
fogged. This condition inhibits the transmission of
light to the retina, causing a painless blurring of vision.
Cataracts are caused by changes in the chemical com-
position of the lens associated with many factors: age,
environment, drugs, systemic diseases, traumatic eye
injuries, certain diseases of the eye, and genetic or
birth defects. Age-related cataracts are the most com-
mon. If cataracts are not treated, progressive vision
loss leading to significantly impaired sight can occur.

211233 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

424-008 Telephone +1 (610) 825-6000 ● Fax +1 (610) 834-1275 ● E-mail hpcs@ecri.org
Healthcare Product Comparison System

quicken visual rehabilitation, and decrease surgical via the I/A attachment. Either a polymethyl methacry-
complications. late (PMMA) or a foldable silicone IOL is inserted
through the incision and into the bag of the capsule,
Principles of operation which is then sutured; however, self-sealing, suture-
less corneal incisions are becoming more widely used
Phacoemulsification is one type of extracapsular for phacoemulsification procedures.
cataract extraction, a procedure that removes the lens
nucleus, the surrounding cortex, and the enclosing Typical phacoemulsification systems integrate into
anterior capsule; the zonules and posterior capsule are a single handpiece the I/A and US capabilities needed
left intact to help support an IOL implant (see Fig. 1). to break up and remove a cataractous lens from the
eye. The surgeon typically activates these capabilities
During a phacoemulsification procedure, the sur-
by depressing a single footpedal.
geon performs several steps with the aid of an operat-
ing microscope (see the Product Comparison titled Saline solution is used as the irrigant; mounted on
MICROSCOPES, OPERATING). an adjustable intravenous (IV) pole, its pressure head
can be controlled by adjusting its height. The irrigation
A 2.8 to 3.5 mm incision is made to gain access to
line runs from the irrigation bottle and passes through
the eye’s anterior chamber. A viscoelastic material is
a pinch valve before being connected to a handpiece
then infused to deepen the anterior chamber and pro-
(US, I/A, and anterior vitrectomy handpieces all have
tect the corneal endothelium.
tubing connections for irrigation and aspiration lines).
After removing the anterior lens capsule and hy- When the valve opens, fluid flows into the eye through
drodissecting the lens to separate it from the cortex an irrigation sleeve that surrounds the tip. The sur-
and capsule (by injecting fluid under the anterior cap- geon prevents the anterior chamber of the eye from
sule and into the cortex), the surgeon inserts a phacoe- collapsing by balancing the irrigation flow with the
mulsification probe, which consists of a hollow, aspiration fluid loss and wound leakage.
cylindrical tip surrounded by an irrigation sleeve. The
probe tip, when electrically activated, oscillates rap- The aspiration line runs from the handpiece to a
idly, creating ultrasonic waves that cut tissue. The vacuum pump and a collection container. Aspiration
surgeon emulsifies the cataractous lens using shaving vacuum is used to hold the lens nucleus and larger
or scooping motions of the probe. The lens fragments fragments to the US tip, where they can be emulsified;
are then aspirated from the eye through the hollow tip smaller fragments and irrigant are then aspirated into
of the phacoemulsifier. Remaining cortex is aspirated a collection container through the aspiration line. As-
piration also aids in cooling by moving fluid through
the probe tip. I/A systems commonly use peristaltic,
Aqueous
Anterior diaphragm, or venturi pumps to create a vacuum. In
Capsule Cornea
Humor most diaphragm and venturi pump systems, only the
Conjunctiva
Ciliary Body vacuum levels can be set; the rate at which objects are
Anterior drawn to the tip — the aspiration flow — can be
Iris
Chamber Anterior changed only by adjusting these levels. Peristaltic
Posterior Segment pump systems, on the other hand, can alter the flow by
Lens
Chamber
varying the speed of the pump; a separate vacuum
Posterior Zonule control is used to adjust the maximum vacuum at the
Capsule Fibers
probe tip. Individual control of these two parameters
Vitreous Humor is very useful during certain phases of phacoemulsifi-
Retina Fovea
cation. New aspiration systems alter the flow rate as
a function of achieved vacuum.
Disk
Additional fluidic components provide venting of
the aspiration line to relieve vacuum (e.g., when the
Choroid
surgeon stops aspiration by releasing the footpedal)
and reflux to flush obstructions out of the aspiration
Sclera flow path and move tissue away from the tip.
C242UN2A

Optic Nerve Macula Lutea The US system of the phacoemulsifier consists of a

generator that produces an ultrasonic signal and a
Figure 1. Anatomy of the eye handpiece that uses either a piezoelectric or a magne-
tostrictive transducer to vibrate the handpiece tip,

2 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.

causing it to break up the cataractous lens. Handpieces
are lightweight, typically between 1 and 5 oz (28.3 and
141.7 g); some are constructed in one piece, while
others can be disassembled for cleaning and routine
maintenance. The transducers are either air or water
cooled to prevent them from overheating. Irrigation
and aspiration lines may run along the outside or the
inside of the casing; most handpieces can be steam
autoclaved. US tips can be either reusable or dispos-
able and are beveled at various angles at the operative
end. Some handpieces permit the bevel to be positioned
to the surgeon’s preference after the tip is secured to
the core of the handpiece. Irrigation and aspiration
flow cool the tip to prevent thermal trauma to the eye.
The ability of the US handpiece to emulsify a lens is
determined by the amplitude (stroke length) and fre-
quency of the vibrating tip; the shape and sharpness
of the tip; the ability of the handpiece to maintain the
resonance, or natural frequency, of the vibrating com-
plex (consisting of the handpiece, the tip, and the object
contacting the tip); and aspiration. Most US systems
have a continuous autotuning feature that allows the
generator to adjust its output signal to match the
changing resonance of the handpiece system. This
feature not only eliminates the need for manual tuning
but also increases the efficiency of the phacoemulsifi-
cation circuit and the tip.
Phacoemulsification systems typically have front-
panel controls that the surgeon can change to choose
modes and settings specific to procedure and personal
technique. The system can also contain components for
other aspects of cataract surgery (e.g., anterior vitrec-
tomy for vitreous humor removal, bipolar diathermy
for bleeding control). Front-panel controls are used to
select phacoemulsification output levels, vacuum lim-
its, irrigation rate, and other parameters, as well as
the modes of operation (e.g., irrigation only, I/A, US);
however, only one mode can be operational at a time.
The physician controls the unit by progressively de-
pressing the footpedal to three operating positions. In
the first position, the irrigation valve is opened; it
remains open during further pedal depression. The
next position activates the aspiration pump to reach
the set aspiration levels. The last position activates the
ultrasonic generator to power the phacoemulsification
handpiece. Activation of the US handpiece is thus
always accompanied by irrigation and aspiration. Usu-
ally, another switch is available in the footpedal hous-
ing that activates a fluid reflux mode.
In the US or phacoemulsification mode, the surgeon
can control the machine’s function in three ways. The
unit can deliver the preset aspiration vacuum and US
output levels immediately when the surgeon activates
©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Cataract Extraction Units, Phacoemulsification
the footswitch (panel control), or the surgeon can con-
trol either the vacuum level or the US output level
individually by using the footswitch (surgeon or linear
control). For example, in a linear US mode, the hand-
piece output is in direct proportion to the displacement
of the footswitch in the US position — similar to the
way the speed of a car increases when the accelerator
is depressed. Surgeon or panel control of aspiration is
available in most modes (e.g., I/A, anterior vitrectomy).
Most phacoemulsifiers also have an anterior vitrec-
tomy component that is used to excise the vitreous
humor — the clear fibrous gelatinous substance be-
tween the lens and the retina — from the posterior
chamber if the posterior capsule is ruptured during
surgery. The surgeon must cut this material with a
handpiece equipped with a guillotine, oscillating, or
rotating cutter and remove it by aspiration. Several
models permit the user to select the cutting rate on the
front panel; the footpedal also controls the activation
of the handpiece. As in the US mode, irrigation flows
into and aspiration flows out of the eye through the
vitrectomy handpiece.
Some phacoemulsification systems include multi-
modulation phacoemulsification, which involves pre-
setting parameters such as aspiration flow rate,
power, and vacuum pressure for performing nuclear
sculpting, emulsification, and epinuclear removal.
Presetting these parameters can reduce the risk of
posterior capsule rupture and endothelial trauma for
safer and more effective cataract extraction.
Reported problems
A number of cases of thermal lesions to the sclera
and cornea of patients undergoing phacoemulsifica-
tion have been reported to ECRI. Upon investigation,
it was determined that the lesions were not caused by
any instrument malfunction but were the result of
insufficient irrigation and aspiration flow — both of
which help cool the probe tip — that could have been
avoided if proper surgical technique and procedures
were observed. Insufficient irrigation or aspiration can
occur if the irrigation fluid bottle is empty, is posi-
tioned too low for adequate flow, or if the tubing or
sleeve is crimped or compressed. Similarly, aspiration
flow can be inhibited or stopped if the probe tip be-
comes occluded (e.g., by viscoelastic material, by the
lens nucleus), if the vacuum limit is set too low, if the
aspiration tubing becomes crimped, or if the cas-
sette/tubing set is loaded improperly.
In addition, ECRI has received reports of metal
fragments being left in patients’ eyes following phacoe-
mulsification and of phacoemulsification units failing
to vacuum.
3
Healthcare Product Comparison System
Cases have been reported in which the posterior
capsule has been torn when it adhered to the aspira-
tion channel because of a high vacuum. Other reported
cases of capsular rupture have allegedly been caused
by either jagged metal burs on the aspiration tip or a
rough irrigation port on an I/A handpiece.
Postoperative endophthalmitis resulting from bac-
terial contamination has also been reported following
phacoemulsification procedures. Careful disinfection
of operating instruments and postoperative applica-
tion of antibiotic ophthalmic drops or ointment can
reduce the risk of infection. Surgically induced astig-
matism has also occurred; however, newer methods
that involve smaller incisions, as well as advances in
refractive surgery, have reduced the occurrence of
iatrogenic astigmatism.
Furthermore, in one case, a patient sustained a
corneal burn due to apparent cuts or tears in two
sleeves from a Turbosonic kit used in the suction
procedure.
Purchase considerations
After making sure the system is safe and effective,
the surgeon’s most important consideration is whether
he or she is comfortable using the system. The US
handpiece should not feel awkward or heavy in the
surgeon’s hand, the responsiveness of the footpedal
control should be satisfactory, and the system should
deliver the levels of aspiration and US output the
surgeon desires. Ultrasonic capsulotomy, automated
reflux, anterior or posterior vitrectomy, and diathermy
capabilities may come standard with the system or
may be purchased as options. The difference in cost
between disposable and reusable I/A tubing, collection
devices, and other equipment should also be examined;
hospitals that perform many phacoemulsification pro-
cedures should keep in mind that most reusable equip-
ment must be sterilized after every operation.
Service support should be readily available, and
replacement or repair parts should be easily identified
and quickly obtainable from the supplier. The supplier
should also offer free training (preferably on-site) for
the operation and maintenance of the instrument and
provide the user with a clear, concise, and comprehen-
sive instruction manual.
Cost containment
Because phacoemulsification units entail ongoing
maintenance and operational costs, the initial acquisi-
tion cost does not accurately reflect the total cost of
ownership. Therefore, a purchase decision should be
based on issues such as life-cycle cost (LCC), local
4 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
service support, discount rates and non-price-related
benefits offered by the supplier, and standardization
with existing equipment in the department or hospital.
Some suppliers offer significant discounts that are
contingent on the purchase of a certain amount of
supplies and number of IOLs.
An LCC analysis can be used to compare high-cost
alternatives and/or to determine the positive or nega-
tive economic value of a single alternative. For exam-
ple, hospitals can use LCC analysis techniques to
examine the cost-effectiveness of leasing or renting
equipment versus purchasing the equipment outright.
Because it examines the cash-flow impact of initial
acquisition costs and operating costs over a period of
time, LCC analysis is most useful for comparing alter-
natives with different cash flows and for revealing the
total costs of equipment ownership. One LCC tech-
nique — present value (PV) analysis — is especially
useful because it accounts for inflation and for the time
value of money (i.e., money received today is worth
more than money received at a later date). Conducting
a PV/LCC analysis often demonstrates that the cost of
ownership includes more than just the initial acquisi-
tion cost and that a small increase in initial acquisition
cost may produce significant savings in long-term op-
erating costs. The PV is calculated using the annual
cash outflow, the dollar discount factor (the cost of
capital), and the lifetime of the equipment (in years) in
a mathematical equation.
The following represents a sample five-year
PV/LCC analysis for a phacoemulsification unit that
will be used for five procedures a week.
Present Value/Life-Cycle Cost Analysis
Assumptions
• Operating costs are considered for years 1 through 5
• Dollar discount factor is 6%
• Inflation rate is 6% for a full-service contract and
4% for disposables
Capital Costs
• Unit and 2 handpieces = $50,000
Operating Costs
• Disposable phaco packs = $39,000/year
• Service contract, years 3 through 5 = $3,000/year
• Replacement of 2 handpieces in year 3 = $7,500
Total operating costs = $42,000/year ($49,500/year
in year 3)
PV = ($254,008)

As illustrated by the above sample PV/LCC analy-
sis, the initial acquisition cost is only a fraction of the
total cost of operation over five years. Therefore, rather
than making a purchase decision based solely on the
acquisition cost of the unit, buyers should consider
operating costs over the lifetime of the equipment. The
LCCs vary greatly among units due to differences in
the prices for disposables per procedure. In addition,
handpieces can be disposable or have a limited number
of recommended uses. Costs for these items should be
negotiated before a final purchase decision is made.
For further information on PV/LCC analysis, cus-
tomized analyses, and purchase decision support,
readers should contact ECRI’s SELECT™ Group.
Stage of development
Phacoemulsification in the anterior chamber was
first introduced in the late 1960s; during the late
1970s, phacoemulsification in the posterior chamber
was performed. In the 1980s, the power of the phacoe-
mulsification tip was emphasized; however, in the
1990s, the emphasis switched to the aspiration capa-
bilities of the phacoemulsification system and in-the-
bag procedures. Smaller, self-sealing incisions and
foldable silicone IOLs are now being regularly used.
Foldable IOLs can be inserted into the lens capsular
bag through 3 to 4 mm incisions, whereas PMMA IOLs
require 6 to 7 mm incisions.
Recently, a silicone IOL was injected through a 2 mm
incision, with the IOL cartridge remaining outside the
eye; smaller phacoemulsification and I/A tips were also
used. New endolenticular, endocapsular, and one-
handed intercapsular and lens-grooving techniques
are also being developed.
A new protein gel that simulates cataractous hu-
man lenses has been introduced as an aid in teaching
phacoemulsification techniques. The gel can be in-
jected into the capsular bag of a living animal, a
cadaver, or a plastic model head.
At least one manufacturer has developed a laser
cataract emulsification device that is currently being
tested. A laser fiber coupled to an I/A handpiece deliv-
ers Nd:YAG laser energy to a titanium target. Shock
waves collected at the tip of the probe are used to
disrupt the cataractous tissue, which is then aspirated
from the eye. Because the laser probe has no moving
parts, it is compact in size — comparable to a ballpoint
pen — and may be more comfortable for surgeons than
US handpieces.
©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
Cataract Extraction Units, Phacoemulsification
Bibliography
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Ophthalmol 1993 Feb;4(1):39-43.
Cataract Management Guideline Panel. Cataract in
adults: management of functional impairment.
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AHCPR Publication No. 93-0542.
Egger SF, Huber-Spitzy V, Scholda C, et al. Bacterial
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Gimbel HV. Evolving techniques of cataract surgery:
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Guttman C. Laser cataract removal making waves.
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Guttman C. Multi-modulation approach makes phaco
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Guttman C. Which is better: clear corneal or scleral
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19(18):16, 18.
Kelman CD. The history and development of phacoe-
mulsification. Int Ophthalmol Clin 1994 Spring;
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Kershner RM. Sutureless one-handed intercapsular
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Koch PS. Techniques and instruments for cataract
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Maloney WF, Grindle L. Textbook of phacoemulsifica-
tion. Fallbrook (CA): Lasenda Publishers; 1988.
Moyer P. Small-incision surgery gets even smaller.
Ophthalmol Times 1994 Jun 15;19(12):1, 44.
Pacifico RL. Ultrasonic energy in phacoemulsification:
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Sabbagh L. Big gains come from small capsulorhexis.
Ophthalmol Times 1994 Sep 15;19(18):11.
5
Healthcare Product Comparison System
Sabbagh L. ‘V’ groove phaco technique: fast, easy, safe.
Ophthalmol Times 1994 Sep 15;19(18):12.
Sabbagh LB. Gel mimics cataracts, is boon to learning
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Seery J. Phacoemulsification: an improved method of
cataract removal. AORN J 1989 Dec;50(6):1230-4.
Watson A, Sunderraj P. Comparison of small-incision
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cataract surgery: post-operative astigmatism and
visual recovery. Eye 1992;6(Pt 6):626-9.
Wright M. Endocapsular technique, clear-corneal inci-
sion helpful with unusual eyes. Ophthalmol Times
1992 Jul 15;17(14):35.
Standards and guidelines
Note: Although every effort is made to ensure that the
following list is comprehensive, please note that other
applicable standards may exist.
American Academy of Ophthalmology. Cataract sur-
gery in the otherwise healthy adult second eye [in-
formation paper]. Quality of Care Committee. 1991.
American National Standards Institute/Association
for the Advancement of Medical Instrumentation.
Safe current limits for electromedical apparatus
[standard]. 3rd ed. ANSI/AAMI ES1-1993. 1985 (re-
vised 1993).
Center for Practice and Technology Assessment. Cata-
ract in adults: management of functional impair-
ment [guideline]. No. 4. 1993 Feb.
International Electrotechnical Commission. Medical
electrical equipment — part 1: general require-
ments for safety [standard]. IEC 60601-1 (1988-12).
1988.
Medical electrical equipment — part 1: general re-
quirements for safety. Amendment 1 [standard].
IEC 60601-1-am1 (1991-11). 1991.
Medical electrical equipment — part 1: general re-
quirements for safety. Amendment 2 [standard].
IEC 60601-1-am2 (1995-03). 1995.
Medical electrical equipment — part 1: general re-
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Medical electrical equipment — part 1: general re-
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Medical electrical equipment — part 1: general re-
quirements for safety. Section 2. Collateral stan-
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RAND Health. Cataract surgery: a literature review
and ratings of appropriateness and cruciality [ap-
propriateness criteria]. JRA-06. 1992.
U.S. Department of Health and Human Services. U.S.
Food and Drug Administration. Ophthalmic de-
vices. 21 CFR 886. 1999.
Citations from other ECRI publications
Health Devices
Scleral and corneal burns during phacoemulsification
with viscoelastic materials [hazard]. 1988 Dec;
17(12):377-9.
Cataract extraction procedures [clinical perspective].
1989 Nov;18(11):373-6.
Phacoemulsification systems [evaluation]. 1989 Nov;
18(11):377-404.
Metal fragments shed by Storz PREMIERE phacoe-
mulsification units [User Experience Network™].
1993 May-Jun;22(5-6):304-6.
Overheating of phacoemulsifier ultrasound tips [User
Experience NetworkTM]. 1993 Dec;22(12):602.
Misconnection of vitrectomy handpieces and vitrec-
tomy units [hazard]. 1995 Feb;24(2):86.
Update: metal fragments shed by Storz PREMIERE
phacoemulsification units [User Experience Net-
work™]. 1995 Jul;24(7):290.
Scleral and corneal burns during phacoemulsification
[hazard update]. 1996 Nov;25(11):426-31.
Conductor wire fractures of Storz phacoemulsification
handpiece power cords [hazard]. 1997 Jan;26(1):26-7.
Faulty gauge on nitrogen regulator causes decreased
aspiration during a vitrectomy procedure [User Ex-
perience Network™]. 1998 Jul;27(7):269-70.
Health Devices Alerts
This Product Comparison lists Health Devices Alerts
(HDA) citations published since the last update of this
report. Each HDA abstract is identified by an Acces-
sion Number. Recalls and hazard reports include de-
scriptions of the problem involved; abstracts of other
published articles are referenced by bibliographic in-
formation. HPCS subscribers can call the Hotline for
additional information on any of these citations or to
request more extensive searches of the HDA database.
 Cataract Extraction Units, Phacoemulsification

A4553 FDA Class II Recall No. Z-0297-2 of certain Allergan

Bausch & Lomb CX 4310 Storz Ophthalmics Sterile
Concentrix phacoemulsification packs. The irrigation Allergan Inc [178884]
line tubing in the packs may not be properly adhered 2525 Dupont Dr
to the product cassette and may leak or become com- Irvine CA 92612
pletely detached. The distributor initiated a recall by Phone: (714) 246-4500, (800) 347-4500
letter dated October 5, 2001. Verify that you have Fax: (714) 246-6987
received the October 5, 2001, letter, device recall ac- E-mail: corpinfo@allergan.com
knowledgement form, and self-addressed stamped re- Internet: http://www.allergan.com
turn envelope from Bausch & Lomb. Identify and Allergan Ltd [313425]
isolate any affected product in your inventory. Source: The Crown Center
FDA Enforcement Rep 2001 Nov 28; Manufacturer. Coronation Road
D4846 FDA Class II Recall No. Z-780-0 of certain High Wycombe, Buckinghamshire HP12 3SH
Alcon Laboratories model 200PS Accurus Phacoemul- England
sification Systems. The low-pressure air output Phone: 44 (1494) 444722
(AVGFI) module used with the systems may unexpect- Fax: 44 (1494) 473593
edly drop to a low setting, resulting in low irrigation Internet: http://www.allergan.com
or infusion pressure during surgery, while the vacuum
remains active. The firm initiated a field correction by American Optisurgical
letter and telephone beginning on April 25, 2000. The
firm states that no affected product remains on the American Optisurgical Inc [155789]
market. No further action is required of customers. 25501 Arctic Ocean Dr
FDA has designated this recall complete. Source: Lake Forest CA 92630-8827
FDA Enforcement Rep 2000 Jun 14; Manufacturer. Phone: (949) 580-1266, (800) 576-1266
Fax: (949) 580-1270
39512 Tsuneoka H, Shiba T, Takahashi Y. Ultrasonic E-mail: info@optisurgical.com
phacoemulsfication using a 1.4 mm incision: clinical Internet: http://www.optisurgical.com
results. J Cataract Refract Surg 2002 Jan;28(1):81-6.

Healthcare Risk Control Bausch & Lomb

Burns during cataract surgery. 1996;4:Surgery and Bausch & Lomb Surgical Asia Pacific [340066]
anesthesia:11. 10 Anson Rd
#19-16 International Plaza
Singapore
Supplier information Republic of Singapore
Phone: 65 2234440
Alcon Surgical E-mail: kathleen_ten@bausch.com
Internet: http://www.blsurgical.com
Alcon Laboratories Inc [271237]
6201 South Frwy Bausch & Lomb Surgical-Europe [340067]
PO Box 6600 The Enterprise Centre
Fort Worth TX 76134 Easthampstead Road
Phone: (817) 293-0450, (800) 757-9195 Reading, Berkshire RG12 1NF
Fax: (817) 568-7116 England
E-mail: webmaster@alconlabs.com Phone: 44 (1344) 300010
Internet: http://www.alconlabs.com Internet: http://www.blsurgical.com
Alcon SA Laboratoires [279059] Bausch & Lomb Surgical GmbH [340065]
4 rue Henri Sainte-Claire Deville Im Schuhmachergewann 4
F-92563 Rueil-Malmaison Postfach 103360
France D-69023 Heidelberg
Phone: 33 (1) 47104710 Germany
Fax: 33 (1) 47102772 Phone: 49 (6221) 8230
E-mail: webmaster@alconlabs.com Fax: 49 (6221) 823167
Internet: http://www.alconlabs.com Internet: http://www.blsurgical.com

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 7
Healthcare Product Comparison System

Bausch & Lomb Surgical Inc [340064] ERBE USA Inc [108422]
180 E Via Verde 2225 Northwest Pkwy
San Dimas CA 91773 Marietta GA 30067
Phone: (909) 971-5100, (800) 338-2020 Phone: (770) 955-4400, (800) 778-3723
Fax: (909) 971-5124 Fax: (770) 955-2577
E-mail: info_blsurgical@bausch.com E-mail: info@erbe-usa.com
Internet: http://www.blsurgical.com Internet: http://www.erbe-med.com

DORC
Geuder
Dutch Ophthalmic Research Center bv [151223]
Scheijdelveweg 2
Geuder AG [138332]
NL-3214 VN Zuidland
Hertzstrasse 4
The Netherlands
D-69126 Heidelberg
Phone: 31 (181) 458080
Germany
Fax: 31 (181) 458090
Phone: 49 (6221) 306728
E-mail: mailto@dorc.nl
Fax: 49 (6221) 303122
Internet: http://www.dorc.nl
E-mail: info@geuder.de
Dutch Ophthalmic USA [155783] Internet: http://www.geuder.de
1 Little River Rd
PO Box 968
Kingston NH 03848-3020
Howard Instruments
Phone: (603) 642-8468, (800) 753-8824
Fax: (603) 642-8465
E-mail: sales@dutchophthalmicusa.com Howard Instruments Inc [184654]
Internet: http://www.dorc.nl 4749 Appletree Ln
Tuscaloosa AL 35405
Phone: (205) 553-4453
ERBE Fax: (205) 556-9267
Internet: http://www.howardinstruments.com
ERBE Elektromedicina doo [336211]
Tratnikova 22
SI-1210 Ljubljana-Sentvid
Slovenia Nidek
Phone: 386 (61) 5124406
Fax: 386 (61) 5124406 Nidek Co Ltd
E-mail: erbe.slo@s-net.net International Div [175521]
Internet: http://www.erbe-med.com 6/Fl Takahashi Building No 2 3-chome
Kanda-Jinboucho Chiyoda-ku
ERBE Elektromedizin GmbH [156988]
Tokyo 101-0051
Waldhoernlestrasse 17
Japan
D-72072 Tuebingen
Phone: 81 (3) 32880571
Germany
Fax: 81 (3) 32880570
Phone: 49 (7071) 7550
E-mail: ask@nidek.co.jp
Fax: 49 (7071) 755179
Internet: http://www.nidek.co.jp
E-mail: sales@erbe-med.de
Internet: http://www.erbe-med.de
Nidek SA [175496]
ERBE Medical Sarl [336199] 13 rue Auguste
11 Chemin de l’Industrie Perret Europarc
Parc d’Affaires F-94042 Creteil
F-69570 Dardilly (Lyon) France
France Phone: 33 (1) 49809797
Phone: 33 (478) 649255 Fax: 33 (1) 49803208
Fax: 33 (478) 661643 E-mail: info@nidek.co.jp
Internet: http://www.erbe-med.com Internet: http://www.nidek.co.jp

8 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Cataract Extraction Units, Phacoemulsification

Oertli STAAR Surgical France Sarl [397841]

Oertli Instrumente AG [185179] 507 place des Champ-Elysees
Hafnerwisenstrasse 4 Courcouronnes
CH-9442 Berneck F-91026 Evry Ceder
Switzerland France
Phone: 41 (71) 7474200 Phone: 33 (1) 69369393
Fax: 41 (71) 7474290 Fax: 33 (1) 69369594
E-mail: info@oertli-instruments.com E-mail: staar-ulsas@infonie.fr
Internet: http://www.oertli-instruments.com Internet: http://www.staar.com

Surgical Design
Optikon 2000
Surgical Design Corp [101766]
Optikon 2000 International SpA [185774] 4253 21st St
via del Casale di Settebagni 13 Long Island City NY 11101-4906
I-00138 Roma Phone: (718) 392-5022, (800) 458-4344
Italy Fax: (718) 786-2139
Phone: 39 (06) 8888355 E-mail: info@surgical.com
Fax: 39 (06) 8888388
E-mail: sales@optikon.com
Internet: http://www.optikon.com
About the chart specifications
The following terms are used in the chart:
Paradigm Medical List price: Some pricing information has been derived
Paradigm Medical Industries Inc [184655] from list prices reported to ECRI’s in-house infor-
2355 South 1070 West mation services by healthcare institutions and by
Salt Lake City UT 84119 suppliers. A footnote identifies these prices. In
Phone: (801) 977-8970, (800) 942-0671 these instances, suppliers have declined to provide
Fax: (801) 977-8970 HPCS directly with prices and may not have con-
E-mail: sales@paradigm-medical.com firmed the information. These prices are estimates
Internet: http://www.paradigm-medical.com and may or may not reflect discounts, options, spe-
cial packages, and multiple-unit sales. They are
provided for the convenience of our readers.
STAAR Surgical
Abbreviations:
STAAR Surgical AG [186588]
Hauptstrasse 104 AC — Anterior chamber (of the eye)
CH-2560 Nidau
Switzerland CD-ROM — Compact disc — read-only memory
Phone: 41 (32) 3328888
CE mark — Conformite Europeene mark
Fax: 41 (32) 3328899
E-mail: info@staar.com CSA — Canadian Standards Association
Internet: http://www.staar.com
DIN — Deutsches Institut fuer Normung
STAAR Surgical Australasia Pty Ltd [186589]
Unit 9/12 Garling Rd EN — European Norm
Kings Park, NSW 2148
ETL — ETL Testing Laboratories
Australia
Phone: 61 (2) 98317808 FDA — U.S. Food and Drug Administration
Fax: 61 (2) 96223146
Internet: http://www.staar.com I/A — Irrigation/aspiration
STAAR Surgical Co [107095] IEC — International Electrotechnical Commission
1911 Walker Ave
Monrovia CA 91016-4846 ISO — International Organization for Standardi-
Phone: (626) 303-7902, (800) 292-7902 zation
Fax: (626) 303-2962 IV — Intravenous
E-mail: info@staar.com
Internet: http://www.staar.com LCD — Liquid crystal display

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 9
Healthcare Product Comparison System

LED — Light-emitting diode
MDD — Medical Device Directives
MedGV — Medizingeraeteverordnung
RF — Radio-frequency
TUV — Technischer Ueberwachungs Verein
UL — Underwriters Laboratories
US — Ultrasound
VFI — Visual fields intact
Note: The data in the charts derive from suppli-
ers’ specifications and have not been verified through
independent testing by ECRI or any other agency.
Because test methods vary, different products’ speci-
fications are not always comparable. Moreover, prod-
ucts and specifications are subject to frequent
changes. ECRI is not responsible for the quality or
validity of the information presented or for any adverse
consequences of acting on such information.
When reading the charts, keep in mind that, unless
otherwise noted, the list price does not reflect supplier
discounts. And although we try to indicate which
features and characteristics are standard and which
are not, some may be optional, at additional cost.
For those models whose prices were supplied to us
in currencies other than U.S. dollars, we have also
listed the conversion to U.S. dollars to facilitate com-
parison among models. However, keep in mind that
exchange rates change often.
Need to know more?
For further information about the contents of this
Product Comparison, contact the HPCS Hotline at +1
(610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or
hpcs@ecri.org (e-mail).

About ECRI . . .
ECRI is a nonprofit health services research agency and a Collaborating Center of the World Health
Organization, providing information and technical assistance to the healthcare community to support
safe and cost-effective patient care for more than 25 years. The results of ECRI’s research and
experience are available through its publications, information systems, databases, technical assis-
tance program, laboratory services, seminars, and fellowships.

Our full-time staff includes a wide range of specialists in healthcare technology, hospital admini-
stration, financial analysis, risk management, and information and computer science, as well as
hospital planners, attorneys, physicists; biomedical, electrical, electronic, chemical, mechanical, and
registered engineers; physicians; basic medical scientists; epidemiologists and biostatisticians; and
writers, editors, and communications specialists.

Underlying ECRI’s knowledge base in healthcare technology are its integrity and objectivity. ECRI
accepts no financial support from medical product manufacturers, and no employee may own stock
in or consult for a medical equipment or pharmaceutical company.

The scope of ECRI’s resources extends far beyond technology. ECRI keeps healthcare professionals,
manufacturers, legal professionals, information specialists, and others aware of the changing trends
in healthcare, healthcare standards and regulations, and the best ways to handle environmental and
occupational health and safety issues. ECRI also advises on management issues related to healthcare
cost containment, accreditation, risk management, human resources, quality of care, and other
complex topics.

ECRI has more than 35 publications, databases, software, and services to fulfill the growing need
for healthcare information and decision support. They focus on three primary areas: healthcare
technology, healthcare risk and quality management, and healthcare environmental management.

10 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Cataract Extraction Units, Phacoemulsification

Product Comparison Chart

MODEL ALCON SURGICAL ALCON SURGICAL ALLERGAN ALLERGAN

Accurus 800CS Series 20000 Legacy AMO Diplomax AMO Prestige

WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Yes

CE MARK (MDD) Yes Yes Yes Yes

DESIGN Modular (in console) Modular (in console) Modular (in console) Modular (in console)

ULTRASOUND SYSTEM
Handpiece type Piezoelectric * Piezoelectric Piezoelectric Piezoelectric
Construction 1 piece, titanium 1 piece, titanium Stainless steel, Stainless steel,
horn ** horn ** titanium tip titanium tip
Frequency, kHz 40 40 38 47.5
Pulse mode Yes Yes Yes Yes
Cooling Aspiration bypass Aspiration bypass Passive Passive
Autoclavable Yes Yes Yes Yes
I/A SYSTEM
Pump type Venturi Peristaltic/turbo- Peristaltic Peristaltic
peristaltic
Maximum vacuum,
mm Hg 600 625+ 500 500
Reflux method Mechanical reflux Gravity Gravity Gravity

Vents to
Atmosphere Yes No Yes No
Bottle Yes Yes No Yes
Tubing
Reusable/cost Not specified Not specified Optional/not spec Not specified
Disposable/cost Not specified Not specified Yes/not specified Not specified
I/A handpiece
Port diameters, mm 0.2, 0.3, 0.5 metal 0.2, 0.3, 0.5 metal; 0.2, 0.3, 0.4, 0.5 0.3, 0.5
0.3 silicone
Autoclavable Yes Yes Yes Yes
Collection
container size, cc 750 750 1,000 1,000
ANTERIOR VITRECTOMY
Handpiece type Guillotine Guillotine Oscillating or Guillotine
guillotine
Variable speed Yes Yes Yes Yes
Reusable No No Yes No
Autoclavable No No Yes No
OPERATIONAL MODES
Irrigation Continuous Continuous Continuous Continuous
Ultrasound Pulsed, linear Pulsed, linear, Pulsed, burst, Pulsed, linear
phaco burst, bimodal linear
I/A Surgeon vacuum/ Surgeon vacuum/ Surgeon controlled Surgeon controlled
aspiration aspiration or preset or vacuum
Anterior
capsulotomy No No No No
Diathermy Yes Yes Multimode or 1-pulse Linear
Vitrectomy Accurus probe ATIOP Optional side Yes
Others Not specified Steerable I/A Capsule vacuum Capsule vacuum

Colons separate data on similar models of a device. This is the first of

* Also 4 crystals. two pages covering
** Also stainless steel shell, 4 crystals, TurboSonics tip. the above model(s).
These specifications
continue onto the
next page.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 11
Healthcare Product Comparison System

Product Comparison Chart

MODEL ALCON SURGICAL ALCON SURGICAL ALLERGAN ALLERGAN

Accurus 800CS Series 20000 Legacy AMO Diplomax AMO Prestige

DISPLAYS All modes, LCD All modes, LCD LCD screen; all LED and message
screen, 256-color screen, 256-color modes center; all modes
monitor, touchscreen monitor, touchscreen

ADDITIONAL FEATURES
IV pole Automated or manual Automated Automated, Automated,
programmable programmable
Remote control Wireless Wireless, Yes Yes
nondirectional *
Posterior segment Yes No No No

Cart Optional Integrated Detachable from Detachable from

console console
POWER REQUIREMENTS 100/240 VAC, 100/120/220 VAC, 115/220 VAC, 115/220 VAC,
50/60 Hz 50/60 Hz 50/60 Hz 50/60 Hz
H x W x D, cm 50.8 x 48.3 x 52.1 138 x 51 x 57 13 x 38 x 28 20 x 57 x 44

HANDPIECES,
L x diameter, cm 15.9 x 1.3 (1.5 max 15.9 x 1.3 (1.5 max Not specified Not specified
including irrigation including irrigation
line) ** line) **
WEIGHT
System, kg (lb) 40.8 (90) 90 (200) 9 (20), console 24 (53)
Handpieces, g (oz) 80 (2.8) ~80 (2.8) Not specified Not specified

PURCHASE INFORMATION
List price Not specified Not specified $80,000 $70,000

Warranty 1 year 1 year 2 years 2 years

Delivery time, ARO Not specified Not specified Not specified Not specified
Year first sold 1997 1993 1995 1993
Number sold to date 3,000+ 7,500+ Not specified Not specified
Fiscal year Not specified Not specified Not specified Not specified
OTHER SPECIFICATIONS Platform design for 486 central computer Occlusion mode and Smart Pump allows
expandability; full- for expandability; burst mode phaco phaco at very high
featured vitro- advanced user programs; multi- vacuums; onboard
retinal system with interface with 96 modulation phaco and printer; choice of
complete integration memory options; diathermy; maximum- footpedals; 30
of all surgical programmable vacuum indicator; surgeon programs;
functionality. footswitch; AMO MaxPack for maximum-vacuum
continuous higher-vacuum phaco; indicator; choice of
irrigation in US console section phaco handpiece
phaco mode; I/A and detaches for systems.
vitrectomy modes; portability;
various tips avail- footpedal remote
able; units can be control.
upgraded to latest
software & hardware
configuration.

Colons separate data on similar models of a device.

* Also hand proximity sensor for automated backlit.
** Also 375/40 handpiece, 15.9 x 1.3 fragmatome handpiece (Accurus 600DS).

12 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Cataract Extraction Units, Phacoemulsification

Product Comparison Chart

MODEL ALLERGAN AMERICAN BAUSCH & LOMB DORC
OPTISURGICAL
Sovereign Horizon Millennium The Associate
Microsurgical System
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes Not specified

CE MARK (MDD) Yes Submitted Yes Yes

DESIGN Modular (in console) Stand alone Modular, individual Console with
system configuration touchscreen
ULTRASOUND SYSTEM
Handpiece type Piezoelectric * Piezoelectric Piezoelectric * Piezoelectric
Construction Stainless steel, Titanium 1 piece, titanium Titanium
titanium tip
Frequency, kHz 38 40 28 40
Pulse mode Yes Yes Yes Yes
Cooling Passive Passive Air, passive Air
Autoclavable Yes Yes Yes Yes
I/A SYSTEM
Pump type Peristaltic Peristaltic, pro- Venturi, Concentrix Peristaltic or
grammable rise time Venturi
Maximum vacuum,
mm Hg 500 500 550 500
Reflux method Gravity Reflux to bottle Fixed volume Gravity

Vents to
Atmosphere No No Yes No
Bottle Yes/proportional Yes No Yes
Tubing
Reusable/cost Not specified Yes/not specified Yes/not specified Yes/not specified
Disposable/cost Not specified Yes/not specified Yes/various options Yes/not specified
I/A handpiece
Port diameters, mm Titanium AMO 0.2-0.5 0.3, 0.5 0.3, 0.4
Phacofit wide range
Autoclavable Yes Yes Yes Yes
Collection
container size, cc 1,000 500 225, cassette ** 500
ANTERIOR VITRECTOMY
Handpiece type Pneumatic guillotine Pneumatic guillotine Guillotine Guillotine
: Elect oscillation
Variable speed Yes Up to 700 cuts/min 30-750 cuts/min Yes
Reusable No : Yes Yes No Yes
Autoclavable No : Yes Yes No Yes
OPERATIONAL MODES
Irrigation Continuous Yes Yes Continuous
Ultrasound See footnote *** Pulsed/fixed/linear/ Pulsed, linear (6 Pulsed, linear,
burst/multimode programmable), burst fixed
†
I/A See footnote *** Linear vacuum/flow, 4 programmable Linear, preset
panel, fixed-type
Anterior
capsulotomy No No No No
Diathermy 2, linear control Bipolar Bipolar Yes
Vitrectomy 2 Yes Anterior, posterior Yes
Others Flip switch, heel or Burst mode, multi- Dual-linear simulta- Prepared for laser
toe mode footswitch modulation mode, neous control of (phaco and
program, options ultrasound & vacuum/ vitrectomy), high
vitrectomy cut rates vacuum occlusion
technology

Colons separate data on similar models of a device. This is the first of

* Quad-crystal. two pages covering
** Also 500 cc bag. the above model(s).
*** Irrigation (4 multimodes, power pulsed, pulsed, and burst); ultrasound (3 multimodes, linear, linear flow, and vacuum). These specifications
†
Also linear and fixed coagulation, microflow compatible, surgeon-controlled mode switching and parameter adjustments, and continue onto the
unlimited surgeon parameter storage. next page.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 13
Healthcare Product Comparison System

Product Comparison Chart

MODEL ALLERGAN AMERICAN BAUSCH & LOMB DORC
OPTISURGICAL
Sovereign Horizon Millennium The Associate
Microsurgical System
DISPLAYS LCD Presets, US power/ Surgeon name, mode, Color touchscreen
time, average power, preset/actual vacuum with voice
flow, actual vacuum, limits, US power/ confirmation
self-diagnostics, time, vacuum
pulse rate, program, response time, foot-
vacuum rise time switch position *
ADDITIONAL FEATURES
IV pole Automated, No Optional, automated Optional,
programmable programmable
Remote control Yes Yes Infrared included Yes

Posterior segment No No Upgradable, expan- Optional VFI, light,

dable and air/fluid
exchange
Cart Detachable from Yes Optional Yes
console
POWER REQUIREMENTS 100/120/230 VAC, 90/250 VAC, 100-240 VAC, 110/240 VAC,
50/60 Hz 50/60 Hz 50/60 Hz 30/60 Hz
H x W x D, cm 145 x 46 x 64 w/ 21 x 32 x 34.3 52.2 x 53.3 x 50.8, 50 x 45 x 20
cart; 72 x 43 x 51 base unit w/computer
console
HANDPIECES,
L x diameter, cm Not specified 17.2 x 2.3 Not specified 13 x 2

WEIGHT
System, kg (lb) 87 (145) w/cart 10.4 (22.9) 36 (80) w/modules ** 22 (48.5)
Handpieces, g (oz) 83 (2.9) 128 (4.5) Not specified 96 (3.4)

PURCHASE INFORMATION
List price $96,000 $16,000 $50,000-99,000 Not specified
(combined ant/post)
Warranty 2 years 1 year 2 years 1 year

Delivery time, ARO Not specified Not specified 1-3 weeks Not specified
Year first sold 1999 2001 1997 Not specified
Number sold to date Not specified 100 >1,500 Not specified
Fiscal year Not specified Not specified Not specified Not specified
OTHER SPECIFICATIONS Shield system is Multimodulation Color touchscreen; High vacuum sensor
designed for optimum phaco and I/A; user programmable cartridge; suitable
capsular bag pro- programmable; self- languages; surgeon for peristaltic and
tection; coordinates diagnostics; linear parameter file; CD- venturi pump; high
7 microprocessors; bipolar; ROM interactive vacuum occlusion for
onboard printer; re- programmable rise training program; advanced capsular
versible, program- time; sterile tubing floppy drive for protection; sterile
mable footswitch; isolated from parameter transfers; barrier design.
30-surgeon program- equipment by sterile dual-port fiberoptic
ming; open- barrier (eliminates illumination; verti-
architecture phaco risk of cross- cal & proportional
handpiece design; contamination); electric scissors;
White Star software. programmable ErgoTec compatible;
footswitch. bottle infusion and
air/fluid exchange. ***

Colons separate data on similar models of a device.

* Also footpedal programming, bottle height, and bottle infusion.
** Cart with foot controller stored, 50 kg (110 lb).
*** Also includes electric high-speed vitrectomy cutter; viscous fluid injection/evacuation. Meets requirements of CSA and ETL.

14 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Cataract Extraction Units, Phacoemulsification

Product Comparison Chart

MODEL ERBE GEUDER HOWARD INSTRUMENTS NIDEK

Phacotom E : MEGATRON S3 Phacojack CV-24000 A

Aspimat E
WHERE MARKETED Africa, Asia, Worldwide Worldwide Worldwide, except
Australia, Europe, USA
Latin America
FDA CLEARANCE No No Yes No
CE MARK (MDD) Yes Yes Not specified No

DESIGN Modular (in console) Compact unit Single unit Single unit

ULTRASOUND SYSTEM
Handpiece type Piezoelectric Piezoelectric Piezoelectric Piezoelectric
Construction Titanium, stainless Titanium Titanium 1 piece, metallic
steel
Frequency, kHz 28 42.5 40 40
Pulse mode Yes Optional Yes Yes
Cooling Passive Air Air Ambient air
Autoclavable Yes Yes Yes Yes
I/A SYSTEM
Pump type Peristaltic Peristaltic with Peristaltic Peristaltic
venturi effect *
Maximum vacuum,
mm Hg 500 600 500 500
Reflux method Bypass valve, pump Pump reversal Gravity/pump Bottle
reversal reversal
Vents to
Atmosphere Yes Yes Yes No
Bottle Yes No No Yes
Tubing
Reusable/cost Yes/$2.70/procedure Yes/not specified Yes/$3, case Yes/not specified
Disposable/cost No/NA No/NA Yes/$25, case Yes/not specified
I/A handpiece
Port diameters, mm 0.2, 0.3, 0.4, 0.5 0.2, 0.25, 0.3, 0.3 ** 0.3, 0.5
0.35, 0.4, 0.45, 0.5
Autoclavable Yes Yes Not specified Yes
Collection
container size, cc 2,000 1,500 250, bag 500
ANTERIOR VITRECTOMY
Handpiece type Guillotine Guillotine Guillotine, Pneumatic guillotine
disposable
Variable speed Yes Yes Up to 600 cuts/min Yes
Reusable Yes Yes No Yes
Autoclavable Yes Yes No Yes
OPERATIONAL MODES
Irrigation Continuous Continuous Continuous Auto, manual
Ultrasound Pulsed, linear, Pulsed, linear, fix- Pulsed, linear, Pulsed, linear,
constant ed, flash/cool flash *** fixed panel
I/A Linear, fixed; 15 Pulsed, linear, Yes Linear, panel, ad-
preset programs fixed vanced flow control
Anterior
capsulotomy Automatic No Yes No
Diathermy Bipolar Bipolar Bipolar Bipolar
Vitrectomy Yes Pneumatic/magnetic Yes Yes
Others Erbe automated Cold light, air and None specified 3 phases of
bipolar capsulotomy silicone oil injec- phacoemulsification
tion

Colons separate data on similar models of a device. This is the first of

* Venturi plus peristaltic (VIP) dual pump system. two pages covering
** Interchangeable tips: straight, curved, Binkhorst, and others. the above model(s).
*** Also SOS mode. These specifications
continue onto the
next page.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 15
Healthcare Product Comparison System

Product Comparison Chart

MODEL ERBE GEUDER HOWARD INSTRUMENTS NIDEK

Phacotom E : MEGATRON S3 Phacojack CV-24000 A

Aspimat E
DISPLAYS Self-diagnostics, US, vitrectomy, air, Actual and preset US power, pulse,
all modes, US power, infusion, flow rate, US power time, energy; preset
vacuum, US time, vacuum, diathermy, and actual vacuum;
cutting frequency, light, silicone oil, vitrectomy cut rate;
test program, vacuum venturi effect, pro- diathermy; error
rate gram, user * message **
ADDITIONAL FEATURES
IV pole Automated Optional, automated No Automated

Remote control Yes Optional No Yes

Posterior segment Yes Yes *** No Optional

Cart Optional Yes Available Included in single

unit
POWER REQUIREMENTS 110/230 VAC, 110/220 VAC, 110/220 VAC 100, 115, 230±10%,
50/60 Hz 50/60 Hz 49-61 Hz, 400 VA
H x W x D, cm 23.2 x 45.5 x 35 43.5 x 42.5 x 40 30.5 x 38.1 x 11.4 53 x 140 x 58

HANDPIECES,
L x diameter, cm 20 x 1.4 11.5 x 1.2, 12.5 x 15.2 x 1.9 Not specified
1.4, 13.3 x 1.6

WEIGHT
System, kg (lb) 22 (48.5) 19 (41.9) 13 (29) 80 (176.4)
Handpieces, g (oz) 60 (2.1) 89 (3.1) on average 57 (2) Not specified

PURCHASE INFORMATION
List price $36,000 Not specified $12,000 Not specified

Warranty 1 year 1 year 1 year 1 year

Delivery time, ARO 1-3 weeks Not specified Immediate Not specified
Year first sold 1993 2002 1987 Not specified
Number sold to date Not specified Not specified Not specified Not specified
Fiscal year Not specified Not specified January to December April to March
OTHER SPECIFICATIONS 5 user programs; TUV approved. Meets None specified. Programmable;
peristaltic pump requirements of voice information;
with characteristics DIN, EN, EN 46001, optional individual
of venturi pump; and ISO 9001. tubing line for I/A
automatic US-power and phaco; pro-pedal
controlled; remote control; auto pole
control. control; titanium
4 crystal phaco
handpiece;
touchscreen LCD
panel; optional
posterior
capability.

Colons separate data on similar models of a device.

* Also infusion height, self-test, footpedal position, cutting power, preset and actual value, and touchscreen.
** Also IV bottle height, footpedal status, and operation mode.
*** Vitrectomy, linear control of cutting frequency, reusable or disposable cutters, and cold light.

16 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Cataract Extraction Units, Phacoemulsification

Product Comparison Chart

MODEL OERTLI OERTLI OPTIKON 2000 OPTIKON 2000

CataRhex ORBIT OS3 Antares 2000 PULSAR

Minimal Stress
WHERE MARKETED Worldwide Worldwide Worldwide Worldwide

FDA CLEARANCE Not specified Not specified No No

CE MARK (MDD) Yes Yes Yes Yes

DESIGN Portable, w/handle, Modular (in console) Single unit Single unit
fits into pilot case
ULTRASOUND SYSTEM
Handpiece type Piezoelectric Piezoelectric Piezoelectric Piezoelectric
Construction Stainless steel, Stainless steel, Titanium, 4 crystals Titanium
titanium titanium
Frequency, kHz 28 28 40 40
Pulse mode Yes Yes Yes Yes
Cooling Passive Passive Air, passive Air, passive
Autoclavable Yes Yes Yes Yes
I/A SYSTEM
Pump type Peristaltic Peristaltic and Venturi Idrostaltic (peri-
venturi * staltic w/no air)
Maximum vacuum,
mm Hg 500 500 500 500
Reflux method Pump reversal or Pump reversal or Gravity Gravity
IV bottle IV bottle
Vents to
Atmosphere Yes Yes No No
Bottle Selectable Selectable Yes Yes
Tubing
Reusable/cost Yes/$5-7, operation Yes/$5-7, operation Yes/not specified Yes/not specified
Disposable/cost Yes/$34 Yes/$40 Yes/not specified Yes/not specified
I/A handpiece
Port diameters, mm 0.2, 0.3, 0.35, 0.5 0.2, 0.3, 0.35, 0.5 0.3-0.5 0.3-0.5

Autoclavable Yes Yes Yes Yes

Collection
container size, cc 500 500 500 500
ANTERIOR VITRECTOMY
Handpiece type Guillotine Guillotine Guillotine Guillotine

Variable speed Yes Yes Yes Yes

Reusable Yes Yes Yes Yes
Autoclavable Yes Yes Yes Yes
OPERATIONAL MODES
Irrigation Continuous Continuous Continuous Continuous
Ultrasound Pulsed, linear, Pulsed, linear, Panel, linear, Panel, linear
3 program settings 3 program settings ** pulsed
I/A Linear, 2 program Linear, fixed, Panel, linear Panel, linear
settings 3 preset programs
Anterior
capsulotomy Automated RF Automated RF No No
Diathermy Bipolar Bipolar Bipolar Bipolar
Vitrectomy Anterior Yes Yes Yes
Others Automated Kloti Automated Kloti Multimodulation Multimodulation
radio-frequency radio-frequency phaco, adjustable phaco, adjustable
capsulotomy, capsulotomy, rise time rise time, up-
multimode phaco- multimode phaco- gradable to posteri-
emulsification emulsification or segment surgery

Colons separate data on similar models of a device. This is the first of

* Switchable during surgery. two pages covering
** Also pulsed linear mode and burst. the above model(s).
These specifications
continue onto the
next page.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 17
Healthcare Product Comparison System

Product Comparison Chart

MODEL OERTLI OERTLI OPTIKON 2000 OPTIKON 2000

CataRhex ORBIT OS3 Antares 2000 PULSAR

Minimal Stress
DISPLAYS Self-diagnostics, Self-diagnostics, Preset and actual Preset and actual
all modes, actual US all modes, actual US vacuum, flow, tip vacuum, flow, tip
power, US time, flow power, US time, flow stroke, pulse rate, stroke, pulse rate,
rates, cutting rates, cutting diathermy power, diathermy power,
power, error power, error elapsed time, error elapsed time, error
messages messages message, rise time message, rise time
ADDITIONAL FEATURES
IV pole No Automated Automated Automated

Remote control No Yes Optional Optional

Posterior segment No Yes * Yes Yes

Cart Can be mounted to Optional Optional Optional

any IV pole
POWER REQUIREMENTS 85-265 VAC, 85-265 VAC, 100/240 VAC, 100/240 VAC,
48-62 Hz 48-62 Hz 50/60 Hz 50/60 Hz
H x W x D, cm 24 x 22 x 16 15 x 38 x 35 25 x 36 x 38 12 x 35.5 x 36.5

HANDPIECES,
L x diameter, cm 13 x 1.3 US, 11 x 13 x 1.3 US, 11 x 13 x 1.2 13 x 1.2
0.7 I/A, 12 x 1 0.7 I/A, 12 x 1
vitrectomy vitrectomy
WEIGHT
System, kg (lb) 6 (13) 15 (33) 22 (48.5) 12 (27.5)
Handpieces, g (oz) 80 (2.8) US, 15 80 (2.8) US, 15 39 (1.4) 39 (1.3)
(0.5) I/A, 45 (1.6) (0.5) I/A, 45 (1.6)
vitrectomy (w/motor) vitrectomy (w/motor)
PURCHASE INFORMATION
List price $25,000, with 2 $50,000, with 2 Not specified Not specified
sets of instruments sets of instruments
Warranty 2 years 2 years 1 year 1 year

Delivery time, ARO 1-3 weeks 1-3 weeks Not specified Not specified
Year first sold 1997 2001 2000 1995
Number sold to date >450 >100 Not specified 1,000
Fiscal year Not specified Not specified January to December January to December
OTHER SPECIFICATIONS Multimodulation- Footpedal position Minimal stress tech- Minimal stress
phaco/IA; AC guard indicated by sound; nology to select tip technology to
protects against upgradable system; stroke for consist- select tip stroke
collapses. Meets AC guard protects ency regardless of for consistency
requirements of against collapses; nucleus hardness regardless of
CE mark and automatic activation and age of hand- nucleus hardness
IEC 601-2-2. of venturi pump for piece; maximum and age of hand-
posterior segment handpiece stroke piece; maximum hand-
applications; measurement; piece stroke meas-
modules can be used anterior-chamber urement; anterior-
as a complete system surge suppression chamber surge
or as stand-alone system; voice suppression system;
units. Meets prompting; adjust- voice prompting; ad-
requirements of IEC able rise time; justable rise time;
601-1 and 601-2-2 automated I/A system automated I/A system
and MedGV certifi- check; dual linear check; dual linear
cate 01-M-263/93. control footswitch. control footswitch.

Colons separate data on similar models of a device.

* Linear control for vitreous cutter and scissors, aspiration and cutting independently controllable, illumination with 2
exits, gas/fluid exchange unit.

18 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Cataract Extraction Units, Phacoemulsification

Product Comparison Chart

MODEL OPTIKON 2000 PARADIGM MEDICAL PARADIGM MEDICAL PARADIGM MEDICAL

QUASAR Photon Precisionist 30,000 SIStem

WHERE MARKETED Worldwide Worldwide, except Worldwide Worldwide

United States

FDA CLEARANCE No No Yes Yes

CE MARK (MDD) Yes Yes Yes No

DESIGN Single unit Single unit Single unit Single unit

ULTRASOUND SYSTEM
Handpiece type Piezoelectric Piezoelectric Piezoelectric Piezoelectric
Construction Titanium Stainless steel Stainless steel Stainless steel

Frequency, kHz 40 40 40 40
Pulse mode Yes Yes Yes Yes
Cooling Air, passive Air Air Air
Autoclavable Yes Yes Yes Yes
I/A SYSTEM
Pump type Peristaltic Peristaltic Peristaltic Miniperistaltic

Maximum vacuum,
mm Hg 500 500 500 500
Reflux method Gravity Pump reversal Pump reversal From bottle

Vents to
Atmosphere No No No No
Bottle Yes Yes Yes Yes
Tubing
Reusable/cost Yes/not specified Yes/$486, box Yes/$486, box Yes/$10, case
Disposable/cost Yes/not specified Yes/$325, box Yes/$325, box Yes/$45
I/A handpiece
Port diameters, mm 0.3-0.5 0.3, 0.5, 0.7 0.3, 0.5, 0.7 0.3, 0.5

Autoclavable Yes Yes Yes Yes

Collection
container size, cc 500 500 500 500
ANTERIOR VITRECTOMY
Handpiece type Guillotine Guillotine Guillotine Pneumatic guillotine

Variable speed Yes 60-600 cuts/min 60-600 cuts/min 100-600 cuts/min

Reusable Yes Yes Yes No
Autoclavable Yes Yes Yes No
OPERATIONAL MODES
Irrigation Continuous Yes Yes Yes
Ultrasound Panel, linear Pulsed, linear Pulsed, linear Pulsed, linear,
fixed
I/A Panel, linear Linear aspiration Linear aspiration Linear aspiration &
vacuum, 2-stage
Anterior
capsulotomy No No No No
Diathermy Bipolar Fixed Fixed Fixed and linear
Vitrectomy Yes I/A/C I/A/C I/A/C, I/C/A
Others Not specified Full-time antisurge, Full-time antisurge, Selectable anti-
selectable and fully selectable and fully surge, selectable
programmable vacuum programmable vacuum and fully program-
rise time rise time mable vacuum rise
time

Colons separate data on similar models of a device. This is the first of

two pages covering
the above model(s).
These specifications
continue onto the
next page.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 19
Healthcare Product Comparison System

Product Comparison Chart

MODEL OPTIKON 2000 PARADIGM MEDICAL PARADIGM MEDICAL PARADIGM MEDICAL

QUASAR Photon Precisionist 30,000 SIStem

DISPLAYS Preset and actual Actual and preset Actual and preset Actual and preset
vacuum, flow, phaco power, aspira- phaco power, aspira- phaco power, aspira-
US power and pulse tion rate, vacuum tion rate, vacuum tion rate, vacuum
rate, diathermy rise time & limit, rise time & limit, rise time & limit,
power, elapsed time, pulse & cutter rate, pulse & cutter rate, pulse & cutter rate,
cut rate * elapsed phaco time ** elapsed phaco time elapsed phaco time
ADDITIONAL FEATURES
IV pole Automated Yes Yes Optional

Remote control Optional Yes Yes Yes

Posterior segment No No No No

Cart Optional Yes Yes Optional

POWER REQUIREMENTS 100/240 VAC, 100-240 VAC, 100-240 VAC, 100-240 VAC,
50/60 Hz 50/60 Hz 50/60 Hz 50/60 Hz
H x W x D, cm 12 x 35.5 x 36.5 53 x 66 x 135 53 x 66 x 135 33 x 33 x 35.6

HANDPIECES,
L x diameter, cm 14 x 1.5 17.8 x 1.3 std, 17.8 x 1.3 std 14.3 x 1.2 std,
13.6 x 1.5 laser 13.1 x 1.5 mini

WEIGHT
System, kg (lb) 12 (27.5) 132 (291) 100 (220) 11.3 (25)
Handpieces, g (oz) 65 (2.3) 80 (2.8), std; 80 (2.8), std 168 (5.4), std;
36.3 (1.3), laser 118 (3.8), mini

PURCHASE INFORMATION
List price Not specified Not specified Not specified Not specified

Warranty 1 year 1 year 1 year 1 year

Delivery time, ARO Not specified Not specified Not specified Not specified
Year first sold 1992 1998 1997 1997
Number sold to date 350 Not specified Not specified Not specified
Fiscal year January to December January to December January to December January to December
OTHER SPECIFICATIONS None specified. Fully programmable. Fully programmable. Complete anterior
segment system with
144 user-program-
mable memories;
InstaLink closed-
aspiration network;
fully programmable
vacuum rise time.

Colons separate data on similar models of a device.

* Also average US power and LIN/PNL mode.
** Additional displays: laser activation time, laser power, and repetition rate.

20 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.
 Cataract Extraction Units, Phacoemulsification

Product Comparison Chart

MODEL STAAR SURGICAL SURGICAL DESIGN SURGICAL DESIGN

SONIC WAVE Ocusystem Advantage Ocusystem ART

WHERE MARKETED Worldwide Worldwide Worldwide

FDA CLEARANCE Yes Yes Yes

CE MARK (MDD) Yes Yes Yes

DESIGN Modular Single unit Single unit

ULTRASOUND SYSTEM
Handpiece type Piezoelectric Magnetostrictive Magnetostrictive
Construction 1 piece, stainless See footnote * See footnote *
steel, 4 crystals
Frequency, kHz 41 ** 44 or 50 44
Pulse mode Random pulse capable Adjustable Adjustable
Cooling Water, air Passive Passive
Autoclavable Yes Yes Yes
I/A SYSTEM
Pump type Peristaltic Peristaltic Peristaltic

Maximum vacuum,
mm Hg 600 550 550
Reflux method Gravity Gravity Gravity

Vents to
Atmosphere Yes No No
Bottle No Yes Yes
Tubing
Reusable/cost Yes/not specified Yes/$4.25 Yes/$4.25
Disposable/cost Yes/not specified Yes/$45 Yes/$45
I/A handpiece
Port diameters, mm 0.3 0.2, 0.25, 0.3, 0.4, 0.2, 0.25, 0.3, 0.4,
0.5 0.5
Autoclavable Yes Yes Yes
Collection
container size, cc 500, bag 250, bag 250, bag
ANTERIOR VITRECTOMY
Handpiece type Guillotine Rotary or guillotine Rotary or guillotine

Variable speed Yes Yes Yes

Reusable Yes Rotary or guillotine Rotary only
Autoclavable Yes Rotary or guillotine Rotary only
OPERATIONAL MODES
Irrigation Yes Continuous Continuous
Ultrasound Pulsed, linear, Pulsed, linear, Pulsed, linear,
preset, sonic preset preset
I/A Linear, preset Linear, preset Linear, preset

Anterior
capsulotomy No Yes Yes
Diathermy Bipolar Bipolar Bipolar
Vitrectomy Yes Yes Yes
Others Digital video Wireless remote Wireless remote
capable, touchscreen control, panel control, panel
monitor, coiled selection selection
aspiration tubing,
sonic mode ***

Colons separate data on similar models of a device. This is the first of

* Titanium body, rigid plastic infusion sleeve or flexible spiral silicone sleeve. two pages covering
** 40-500 Hz in sonic. the above model(s).
*** Also random pulse ultrasound and auto-tuning handpiece. These specifications
continue onto the
next page.

©2002 ECRI. Duplication of this page by any means for any purpose is prohibited. 21
Healthcare Product Comparison System

Product Comparison Chart

MODEL STAAR SURGICAL SURGICAL DESIGN SURGICAL DESIGN

SONIC WAVE Ocusystem Advantage Ocusystem ART

DISPLAYS Actual vacuum level, Doctor memory, self- Self-diagnostics,

aspiration rate, US diagnostics, preset/ preset/actual
& sonic power out- actual vacuum, flow vacuum, flow rate,
put, footswitch po- rate, US time/ US time, US power/
sition, vitrectomy energy, US power/ cutting rate, foot-
cutting rate cutting rate * pedal position
ADDITIONAL FEATURES
IV pole Optional, automated Automated Automated

Remote control Yes Wireless Wireless

Posterior segment No Light source, Light source,

fiberoptics, vitrec- fiberoptics, vitrec-
tomy lenses tomy lenses
Cart Optional Yes Yes

POWER REQUIREMENTS 100/240 VAC, 115/230 VAC, 115/230 VAC,

47/63 Hz 50/60 Hz, 250 W 50/60 Hz, 250 W
H x W x D, cm 16 x 36 x 36 18 x 56 x 35 18 x 56 x 35

HANDPIECES,
L x diameter, cm 14.2 x 0.5 16 x 1.4, 14 x 1.4 16 x 1.4

WEIGHT
System, kg (lb) 11 (24) 16 (35) 16 (35)
Handpieces, g (oz) 108 (3.8) 60 (2.1) 60 (2.1), 50 (1.8)

PURCHASE INFORMATION
List price Not specified $69,000 $54,000

Warranty 2 years, console 1 year 1 year

Delivery time, ARO Not specified 2-4 weeks 2-4 weeks

Year first sold 1990 1999 1980
Number sold to date Not specified >200 >1,000
Fiscal year Not specified Not specified Not specified
OTHER SPECIFICATIONS None specified. 700 memory Permits control of
settings; trilinear vacuum rise time
phaco power; vacuum independent of flow
and flow; venturi- rates; allows vacuum
emulation feature; rise, postocclusion
44/50 kHz phaco to be controlled
handpiece; control by surgeon;
of vacuum rise time preset memory
independent of flow functions; motorized
rates; vacuum rise stand; auto surge
postocclusion con- protection with 2nd
trolled by surgeon; sterile bottle
preset memory eliminates chamber
functions. ** bounce; cobra hand-
piece with solid in-
fusion sleeve elimi-
nates wound burn. ***

Colons separate data on similar models of a device.

* Footpedal position.
** Auto surge protection with 2nd sterile bottle eliminates chamber bounce; cobra handpiece with solid infusion sleeve eliminates
wound burn.
*** Meets the requirements of the City of Los Angeles, IEC 601-1-2, and UL 544 and has a Certificate of Products for Export for
most countries.

22 ©2002 ECRI. Duplication of this page by any means for any purpose is prohibited.