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Usability and Human Factors Engineering (UHFE) Report

Project Name PoVisc® Ophthalmic Viscosurgical Device (OVD)

FID 110772

Project Number N/A

Design Center Fort Worth Surgical R&D

1. Introduction
This document summarizes the UHFE activities and results for ProVisc® Ophthalmic Viscosurgical
Device (OVD) FID 110772 product described in TDOC-0054288 – Intended Use, Indication for
Use and Product Description for ProVisc® per CORP-002580 – MSP: Usability and Human Factors
Engineering for Medical Devices, and in compliance with EN 62366-1 Application of Usability
Engineering to Medical Devices.

This product was developed and launched before existence of a documented process for Usability
and Human Factor Engineering. Consequently, the scope of this document is limited to 1)
describing the user interface, 2) identifying usability risks and their risk control measures, 3)
analyzing post-market surveillance data related to use error and 4) justifying acceptability of the
residual usability risks.

This document supersedes previous Usability Engineering File Report Summary RD-20090825-
154108-0002.

2. Description of intended device users, uses, use environments, and training

2.1. Intended user population(s)

 Trained ophthalmic surgeons and their clinical staff.
 Patients requiring cataract surgery or anterior segment surgery.

2.2. Intended uses and operational contexts of use:

ProVisc® Ophthalmic Viscosurgical Devices (OVD) Intended Use and Indication for use are
captured in TDOC-0054288.
Consistently, with its labeling and Directions for Use:
 The prefilled syringe is stored in cold (2-8ºC) storage conditions.
 The nurse assembles the cannula to the prefilled syringe and hands the assembled
ProVisc® to the surgeon after attaining room temperature.
 The surgeon expresses the OVD through the cannula into the anterior chamber of
the patient.
 Before completing the surgery, the surgeon completely removes the OVD by
irrigation and aspiration.

SOP REFERENCE: CORP-002580, VER2.0, EXHIBIT 5

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2.3. Use environments and key considerations

The product:
 Is stored in a refrigerator between 2°C and 8°C (36°F - 46°F) in a clinic or hospital
 Reaches temperature of an operating room before use
 Is injected into a patient’s eye where it remains for less than 60 min
 Is removed from the eye via irrigation and aspiration

2.4. User Training

A Direction for Use (DFU) pamphlet is provided with each product providing detailed
instructions.
Ophthalmic surgeons learn how to use this type of products during their medical training.
There is no specific training program for this product.

3. Description of device user interface

3.1. Graphical depiction (drawing or photograph) of device user interface

The user interface is illustrated below using representative graphics of the product.

Figure 3-1: ProVisc® carton and assembled prefilled syringe

Figure3-2: Back of ProVisc® blister pack

SOP REFERENCE: CORP-002580, VER2.0, EXHIBIT 5

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Figure 3-3: Front of ProVisc® blister pack

Figure 3-4: ProVisc® before assembly

Figure 3-5: ProVisc® expiration date

3.2. Verbal Description Of Device User Interface

Table 3.2-1 Description of User Interface
User Interface Element User Interface Description
Packaged Product  Sealed cardboard carton (see Figure 3-1) with printed product
name, storage conditions and expiration date containing:
o Tyvek®-sealed, sterile blister pack with product name, lot
number and printed expiration date (see Figure 3-2 and 3-5)
o Directions for Use insert
Blister Pack  Prefilled glass syringe with:
o Printed product name, lot number and expiration date
o Cap
o Green plunger
 Cannula with:
o Cap to protect stainless steel cannula
o Green cap to protect locking mechanism
 Green locking ring
Note: the locking ring is screwed around the cannula to the syringe to
prevent ‘harpooning’.

SOP REFERENCE: CORP-002580, VER2.0, EXHIBIT 5

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3.3. Device Labeling

The labeling consists of:
 Carton showing product name with the elements listed in Sec. 3.2.
 A DFU insert providing directions for use, indication, warnings, contra-indications.
 Primary label, e.g., Tyvek® seal, information with the elements listed in Sec. 3.2.
 Information printed on the syringe with the elements listed in Sec. 3.2.

3.4. Overview of Operational Sequence

The operational sequence is identified in Table 3.4-1.

Table 3.4-1: Task Analysis

# Environment Users Tasks Steps
1 Store OVD 1. Store OVD in refrigerator (2 to 8ºC)
2. Pull packaged product from storage
Nurse or clinical
Storage Area 3. Confirm OVD selection and expiration date
supply manager
2 Select OVD package (from carton)
4. Inspect secondary package for damage
5. Transfer to surgical suite
3 Open OVD package 6. Open carton and remove blister and DFU
7. Reads DFU
8. Confirm OVD selection and expiration date
4 Inspect content
(from blister)
9. Inspect blister seal integrity
5 10. Allow OVD to attain room temperature (20 –
40 minutes depending on quantity)
11. Open blister pack
Surgical Nurse
12. Transfer content to sterile field
13. Remove cannula caps
Assembles OVD 14. Fill cannula with irrigation solution
6 syringe and cannula 15. Remove protective caps
16. Assemble cannula to syringe
17. Assemble threaded locking ring
Surgical suite
18. Tighten until locked
19. Express air bubbles
20. Dispose of packaging materials and caps
21. Verify cannula lock
22. Insert cannula in eye
23. Depress plunger to express desired fill
volume
7 Use OVD
24. Stabilize anterior segment of the eye
Surgeon 25. Remove cannula from eye
26. Dispose of used syringe and cannula as
surgical waste
27. (complete surgery)
8 Removal of OVD
28. Irrigate and aspirate OVD from eye
9
Disposal of used 29. Dispose of used OVD
OVD

SOP REFERENCE: CORP-002580, VER2.0, EXHIBIT 5

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4. Summary of known use problems

4.1. Known problems with previous models of the subject device

The product was first launched in 1995 with a locking ring mechanism interface to attach the
cannula to the syringe and reduce the risk of ‘harpooning,’ e.g., sudden expulsion of the
cannula upon depression of the plunger, previously observed with Viscoat (see
004:38430:0298).
A Post-Production Risk Review (PPRR) meeting was conducted on 13th August 2018 to
review data collected between 1st April 2013 and 31st December 2018 in accordance with
CORP-003063 – MSP: Post Production Risk Review for Alcon Products (see REP-043045).
The following sections summarize results and conclusion of this meeting regarding potential
use errors:
 Technical Complaints (AEs) reporting rate was less than 5 counts-per-million (CPM).
 Toxic Anterior Segment Syndrome (TASS), Inflammation-Ocular-Other, and
Endophthalmitis AEs could be potentially attributed to use error per Risk Management
Report (TDOC-0054300).
 Technical complaints reporting rate was less than 40 CPM.
 Leakage, Damage-Unspecified, Product-Dispense and Foreign-Materials-in-Product
complaints were reported at a rate of less than 10 CPM. The leakage was determined
to have resulted from an insufficient tightening of the locking ring – with no impact to
safety consistently with Risk Management Report (TDOC-0054300).

4.2. Known problems with similar devices

The risk of ‘cannula blow off,’ e.g., sudden expulsion of the cannula upon depression of the
plunger, was previously observed with Viscoat when using a Luer interface to assemble the
cannula to the syringe (see 004:38430:0298 Rev. 0). This risk was controlled by replacing the
Luer with a locking ring (see 004:38430:0298). ProVisc® includes a locking ring.

4.3. Design modifications

No significant design changes have been made to the user interface after launch.

5. Analysis of hazards and risks associated with use of the device

An analysis of use error risks is provided in Table 5-1 using the Perception-Cognition-Action
task analysis tool:

SOP REFERENCE: CORP-002580, VER2.0, EXHIBIT 5

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Table 5-1: PCA Task Analysis

Task Task Human Component User Error Analysis Risk Consequence & Risk Control Measure
# (Perception, Resulting Harm (with
Cognition, Action) Severity per CORP-
000970)
1. Nurse or P – User reads P – Does not see OVD effectiveness is lost  Secondary label uses
clinical supply secondary storage temperature exposed to low or high standard symbol
manager stores packaging requirement temperature potentially identify storage
OVD in dark resulting in ocular tissue conditions.
and cold C – User C – Label not damages (S=4)  DFU includes storage
conditions (2- understands label understood conditions
8ºC)
A – User places A – Does not store
OVD in refrigerator product within 2-8ºC
2. Nurse or P – User reads label P – Cannot read label Incorrect or expired OVD  All labeling font sizes
clinical supply is selected and used on are greater than or
manager C – User C – Label not patient resulting in: equal to 5.5, which is
selects OVD understands label understood  Unexpected post- the minimum threshold
from storage for operative refraction - recommended by
use in the A – User selects A – Incorrect OVD intervention required AAMI HE75
surgical suite OVD for surgery selection (S=3)  Carton, primary label
 Decreased Vision – and syringe display
Temporary expiration date
(moderate) (S=3)
3. Nurse opens P – User sees or P – No risk No risk resulting in harm, N/A
OVD package feels carton seal delay of surgery
C – No risk
C – User knows how
to open carton A – User opens
package forcefully or
A – User opens uses tools to open
carton carton
4. Nurse inspects P – User reads label P- Cannot read label Incorrect or expired OVD  All labeling font sizes
content and DFU is selected and used on are greater than or
including DFU C – User patient resulting in: equal to 5.5 which is
and sealed understands label C- Label is not  Unexpected post- the minimum threshold
blister and DFU understood operative refraction - recommended by
intervention required AAMI HE75
A – User selects A- OVD does not (S=3)  Carton, primary label
OVD for surgical use match carton labeling  Decreased Vision – and syringe display
and the incorrect OVD Temporary expiration date
is used (moderate) (3)
5. Nurse allows P – User feels P- No risk No risk resulting in harm,  DFU instructs user to
OVD to reach temperature delay of surgery wait 20-40 min.
room C- No risk  User will feel cold
temperature C – User temperature and wait
Acknowledges A- No risk
correct temperature

A – User inspects
cannula
6. Nurse P – sees locking ring P – N/A No risk: as anterior  DFU instructs to purge
assembles chamber surgeries often air before expression in
cannula to C – recognizes how C – N/A introduce air bubble into the eye and to lock
prefilled syringe to use it or check the eye, surgeon will ring.
DFU A – does not fill remove potential bubbles  Air bubble
cannula with saline management is
A – inject saline No risk: if locking ring is common practice.
solution then not tight, OVD may leak  Locking ring
assemble cannula to with no risk of harm mechanism prevents
syringe and lock ring accidental expulsion
Cannula may blast off if (blast off)
not properly locked in
(S=4)

SOP REFERENCE: CORP-002580, VER2.0, EXHIBIT 5

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Task Task Human Component User Error Analysis Risk Consequence & Risk Control Measure
# (Perception, Resulting Harm (with
Cognition, Action) Severity per CORP-
000970)
7. Surgeon inserts P – User inserts and P- Standard surgical No risk resulting in harm,  Surgery performed
cannula in the uses OVD risks delay of surgery under aseptic
eye and conditions
expresses OVD C – User stabilizes C- Standard surgical
anterior segment of risks
the eye
A- Standard surgical
A – User safely risks
performs procedure
8. Surgeon P – sees OVD P- does not see it Elevated IOP – transient  DFU recommends to
removes OVD (S=3) remove OVD
C – User knows how C- forgets about OVD  IOP is monitored
to remove OVD immediately after
A- cannot remove it surgery
A – irrigate and  OVD is removed by
aspire OVD irrigation and aspiration
systems
9. Surgeon P – sees used OVD P- No risk Contaminated OVD may  Labeling indicates
disposes of infect patient (S=3) ‘single use’
used OVD C – Knows to C- Decide to reuse  Surgeon knows how to
dispose of used dispose of biohazards
OVD A- Improper disposal

A – dispose OVD

SOP REFERENCE: CORP-002580, VER2.0, EXHIBIT 5

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6. Summary of preliminary analyses and evaluations

Risks were analyzed via Risk Management Reports (TDOC-0054300).

7. Description and categorization of critical tasks

See Section 3.4

8. Details of human factor validation testing

As this device was developed before a Usability and Human Factor Engineering process was
defined, no specific human factor testing was completed. However, effectiveness of the device
and its user interface was considered in the Clinical Evaluation Report (TDOC-0053208).

9. Conclusion

Use error risks and their risk control measures have been identified in this document from the post-
production risk review and a PCA Task Analysis. All use error risks have been reduced as far as
possible. Residual use error risks cannot be further reduced.

Based on the results contained in the Post Production Risk Review, the residual risk associated with
the User Interface of the ProVisc® Ophthalmic Viscosurgical Device is acceptable per the criteria in
CORP-00970. All the risk numbers listed in Section 5 of this report are consistent with those reported
in the Risk Management Reports and indicate no additional risk concerns. The conclusion of this
report is that the ProVisc® Ophthalmic Viscosurgical Device is safe and effective when used in
accordance with the manufacturer’s directions for use.

10. References

TDOC-0054300 Risk Management Report for ProVisc®

TDOC-0054288 Intended Use, Indication for Use and Product
Description of Ophthalmic Viscoelastic OVDs
(OVDs)
TDOC-0053208 Clinical Evidence Report for ProVisc®
TDOC-0006141 Stability Report for ProVisc®
CORP-003063 MSP: Post Production Risk Review for Alcon
Products
CORP-002586 Global Harms List – Application to Alcon Medical
Devices
CORP-002580 MSP: Usability and Human Factors Engineering
for Medical Devices
CORP-000970 Risk Management – Application to Alcon
Products
EN 623661-1:2015/AC:2015 Application of Usability Engineering to Medical
Devices
EN ISO 15798 Ophthalmic implants - Ophthalmic viscosurgical
devices - Amendment 1
RD-20090825-154108-0002 Usability Engineering File Report Summary
REP-043045 Post-Production Risk Report for ProVisc®
004:38430:0298 Modified Viscoat Package Systems Functional
Testing
MFG074 Stability Report for ProVisc®

SOP REFERENCE: CORP-002580, VER2.0, EXHIBIT 5