HTVP-17006-00 : Light viewer

HTVP-17007-00 : Loupe (X4)

HTVP-17008-00 : Gauge box
HTVP-17009-00 : Digital Thermometer
HTVP-17010-00 : Temperature Recorder len Production Area
HTVP-17011-00 : Temperature Recorder Final Inspection
HTVP-17012-00 : Temperature Recorder Standard measurement
HTVP-17013-00 : Temperature Recorder Biological analysis
HTVP-17014-00 : Temperature Recorder Document room
HTVP-17-010 : Qualification of Pin Gauge
HTVP-17-011 : Qualification of Light Meter
HTVP-17-012 : Galileo AX phase 2
HTIQP-17-013 : Loop Strength Test Report sheet
rev.02 (add model iSert 254/255)

HTVP-16002-00, HTVP-16002-01
HSOT IOL Manufacwturing Factory

S
t
a
HTIQOQP-17-001 : NIMO for In-process Inspection n
d
HTIQOQP-17-002 : NIMO for Final Inspection a
HTPQPVP-17-003 : Re-PQ 250 r
HTIQP-17-004 : Loop Strength Test Report sheet d
M
HTOQPP-17-006 : UDI Water System (Additional) e
a
s
u
r
 e
m
B
e
ni
ot
l
o
g
HTVP-16095-00: Analysis Balance i
c
a
l
A
n
a
l
y
s
i
L
s
e
n
HTVP-16021-00: PGM solution agitator s
P
with Water Bath r
o
HTVP-16022-00: Drying Oven d
u
c
ti
o
n
A
r
L
e
e
a
n
s
HTVP-16027-00: Interferometer P
r
o
d
HTVP-16028-00: Hot Plate u
c
ti
o
n
A
 r
e
L
a
e
n
HTVP-16023-00: Digimatic Tachometer s
P
HTVP-16024-00: Digimatic Micrometer r
o
HTVP-16025-00: Digimatic Caliper d
u
HTVP-16026-00: Tool Makers Microscope c
ti
o
n
A
r
e
C
a
a
r
t
ri
HTVP-16034-00: Sartorius Analytical d
g
Balance e
P
r
o
c
e
s
s

C
a
r
t
ri
d
HTVP-16032-00: RF Plasma Generator g
e
P
r
o
c
e
s
 s

C
a
r
HTVP-16031-00: Drying Oven t
ri
HTVP-16032-00: RF Plasma Generator d
g
HTVP-16033-00: Clean Stocker e
P
HTVP-16035-00: Mag-Mixer r
o
c
e
s
s

L
e
n
s
HTVP-16029-00: Ultrasonic washer P
r
o
d
HTVP-16030-00: Clean Stocker u
c
ti
o
n
A
r
e
C
a
a
r
t
HTVP-16050-00: Instrument Drying Oven ri
d
g
e
HTVP-16051-00: Digimatic Tachcometer P
r
o
c
e
s
 s

HTVP-16002-00: HSOT Process Validation

HTPQPVP-17-003: Re-PQ 250

F
i
n
a
l
I
HTVP-16053-00: Clean bench n
s
p
e
c
ti
o
n

C
a
r
t
ri
HTVP-16038-00: Constant Temperature Oven d
g
- Base Coat (Report) e
P
r
o
c
e
s
 s

C
a
r
t
ri
HTVP-16038-00: Constant Temperature Oven d
g
- Base Coat (Report) e
P
r
o
c
e
s
s

C
a
r
t
ri
HTVP-16038-00: Constant Temperature Oven d
g
- Base Coat e
P
r
o
c
e
s
s

C
a
r
t
HTVP-16036-00: Fume hood ri
d
g
e
HTVP-16037-00: Timer P
r
o
c
e
s
 s

C
a
r
t
ri
HTVP-16034-00: Sartorius Analytical Balance d
g
e
P
r
o
c
e
s
s

C
a
r
t
ri
HTVP-16044-00: Constant Temperature Oven d
g
- Top Coat e
P
r
o
c
e
s
s

C
a
r
t
HTVP-16042-00: Refrigerator ri
d
g
e
HTVP-16043-00: 12-channel Pipette P
r
o
c
e
s
s
 L
e
n
s
HTVP-16014-00: Temperature Recorder P
r
o
d
HTVP-16016-00: Compound Microscope u
c
ti
o
n
A
r
e
L
a
e
n
s
P
r
HTVP-16017-00: Analytical Balance o
d
u
c
ti
o
n
A
r
e
L
a
e
n
s
P
r
HTVP-16018-00: NIMO (In-process) o
d
u
c
ti
o
n
A
 r
e
L
a
e
n
s
HTVP-16019-00: Polishing Machine P
r
o
d
HTVP-16020-00: Ultrasonic cleaner (IOL) u
c
ti
o
n
A
r
e
F
a
a
c
il
1. UDI water system URS,FDS it
y
2. HTVP-16003-00: IQOQ Protocol S
y
3. HTVP-16003-00: IQOQ Report s
t
e
m

F
a
c
il
1. Cleanroom system URS,FDS it
y
2. HTVP-16004-01: IQOQ Protocol S
y
3. HTVP-16004-00: IQOQ Report s
t
e
m
 Qualit
y
Recor
ds of
Device Master Record (DMR) & HTOP-
QA-
002
Process Control Plan (PCP)

Qualit
y
Recor
ds of
QMS document Master List & HTOP-
QA-
002
Document Distribution/Retrieval Records

Qualit
y
Recor
ds of

HTOP-
Management Review meeting minute QA-
004
 Qualit
y
Recor
ds of

HTOP-
Internal Audit Report QA-
005

Qualit
y
Recor
ds of
CAPA report &
HTOP-
QA-
Customer Complaint 006 &
007

Qualit
y
Recor
ds of

HTOP-
MRB report Report and Deviation Request QA-
008
 Qualit
y
Recor
ds of

HTOP-
Change Control Request (CCR) QA-
009

Qualit
y
Recor
ds of

HTOP-
Purchasing- Supplier record QA-
010

Qualit
y
Recor
ds of

HTOP-
Change Control Request (CCR) QA-
009
 Qualit
y
Recor
ds of

Precess Failure Mode & Effects Analysis HTOP-

QA-
(PFMEA) 011

Qualit
y
Recor
ds of

HTOP-
Equipment Control Record QA-
017

Qualit
y
Recor
ds of

HTOP-
Deliverables Review Summary PD-
019
 Qualit
y
Recor
ds of

HTOP-
Document Change Request (DCR) QA-
002
HTIQOQ-18-024-[009] Temperature recorder at chemical mixing room (ST-50A)
HTIQOQ-18-024-[020] Digimatic Caliper at Len cutting (CD-20APX)
HTIQOQ-18-024-[021] Digimetic indicater at Len cutting (ID-F125)
HTIQOQ-18-024-[024] Illuminator for len cutting (LA-100USW)
HTIQOQ-18-024-[028] Illuminator for len treatment (LA-100USW)
HTIQOQ-18-024-[033] Clean bench for mold removal (PCV-1916CS)
HTIQOQ-18-024-[042] Clean bench for len inspection (PCV-1606CS)
HTIQOQ-18-024-[044] Illuminator for len inspection (LA-100USW)
HTIQOQ-18-024-[052] Digimetic indicater IQC (ID-F125)
HTIQ-18-024-[053] Pin gauge IQC
HTIQOQP/R-18-030 UV/Ozone Machine
HTIQOQP/R-18-034 UV Meter
HTIQOQP/R-18-035 Contact Angle Meter

HSOT IOL Manufacturing Factory fo

SP2
 PP Mold Clean Room System

HTIQOQP/R-19-001 Clean Stocker for

FI room
HTIQP/R-19-005 Pin Gauge for IQC
HTIQP/R-19-005 Pin Gauge for IQC
 Work Instruction
of
HR, GA and PD-General
 Device Master Record
(DMR)

Change Control Request

(CCR)
Corrective and Preventive Action
(CAPA)

Approved Vender List

(AVL)
Document Change Record
(DCR)

Document Change Record

(DCR)
 Process Control Plan
(PCP)

Process Failure Mode Analysis

(PFMEA)
Engineering Study
(EDS)
 QA Work Instruction
& Job

Archieve Old Revision of

Form & Appendix
(OBSOLETE)
Management Meeting Report

Pest Control Report

Risk Management Flies

Deviation Request
(DR)
 Internal Audit Report
(IAR)

Intraocular Lensmeter (Nidek)

HTVP-17006-00 HTVP-16091-00 HTVP-16021-00 HTVP-16038-00 REPORT HTVP-16047-00
HTVP-17007-00 HTVP-16092-00 HTVP-16022-00 HTVP-16048-00
HTVP-17008-00 HTVP-16093-00 HTVP-16038-00 HTVP-16049-00
HTVP-17009-00 HTVP-16094-00 HTVP-16023-00
HTVP-17010-00 HTVP-16024-00 HTVP-16036-00 HTVP-16045-00
HTVP-17011-00 HTVP-16095-00 HTVP-16025-00 HTVP-16037-00 HTVP-16046-00
HTVP-17012-00 HTVP-16026-00
HTVP-17013-00 HTVP-16034-00 HTVP-16062-00
HTVP-17014-00 HTVP-16063-00
HTVP-16027-00 HTVP-16044-00
HTVP-17015-00 HTVP-16028-00 HTVP-16059-00
HTVP-17016-00 HTVP-16042-00
HTVP-17017-00 HTVP-16034-00 HTVP-16043-00 HTVP-16057-00
HTVP-17018-00
HTVP-17020-00 HTVP-16032-00 HTVP-16039-00 HTVP-16054-00
HTVP-17021-00 HTVP-16040-00 HTVP-16055-00
HTVP-16031-00 HTVP-16041-00 HTVP-16056-00
HTIQOQP-17-001 HTVP-16032-00
HTIQOQP-17-002 HTVP-16033-00 HTVP-16038-00 REPORT HTVP-16069-00 INSTRUCTIO
HTIQP-17-004 HTVP-16035-00
HTVP-16053-00 HTVP-16069-00
HTVP-16029-00
HTVP-16030-00 HTVP-16050-00 HTVP-16067-00
HTVP-16051-00 HTVP-16068-00

HTVP-16066-00 INSTRUCTIO

HTVP-16066-00
HTVP-16047-00 HTVP-16075-00 INSTRUCTION MANUAL
HTVP-16048-00
HTVP-16049-00 HTVP-16075-00 REPORT

HTVP-16045-00 HTVP-16075-00
HTVP-16046-00
HTVP-16070-00
HTVP-16062-00 HTVP-16071-00
HTVP-16063-00
HTVP-16069-00
HTVP-16059-00

HTVP-16057-00

HTVP-16054-00
HTVP-16055-00
HTVP-16056-00

HTVP-16069-00 INSTRUCTION MANUAL

HTVP-16069-00

HTVP-16067-00
HTVP-16068-00

HTVP-16066-00 INSTRUCTION MANUAL

HTVP-16066-00
HTVP-17006-00 HTVP-16091-00 HTVP-16021-00 HTVP-16038-00 REPORT HTVP-16047-00
HTVP-17007-00 HTVP-16092-00 HTVP-16022-00 HTVP-16048-00
HTVP-17008-00 HTVP-16093-00 HTVP-16038-00 HTVP-16049-00
HTVP-17009-00 HTVP-16094-00 HTVP-16023-00
HTVP-17010-00 HTVP-16024-00 HTVP-16036-00 HTVP-16045-00
HTVP-17011-00 HTVP-16095-00 HTVP-16025-00 HTVP-16037-00 HTVP-16046-00
HTVP-17012-00 HTVP-16026-00
HTVP-17013-00 HTVP-16034-00 HTVP-16062-00
HTVP-17014-00 HTVP-16063-00
HTVP-16027-00 HTVP-16044-00
HTVP-17015-00 HTVP-16028-00 HTVP-16059-00
HTVP-17016-00 HTVP-16042-00
HTVP-17017-00 HTVP-16034-00 HTVP-16043-00 HTVP-16057-00
HTVP-17018-00
HTVP-17020-00 HTVP-16032-00 HTVP-16039-00 HTVP-16054-00
HTVP-17021-00 HTVP-16040-00 HTVP-16055-00
HTVP-16031-00 HTVP-16041-00 HTVP-16056-00
HTIQOQP-17-001 HTVP-16032-00
HTIQOQP-17-002 HTVP-16033-00 HTVP-16038-00 REPORT HTVP-16069-00 INSTRUCTIO
HTIQP-17-004 HTVP-16035-00
HTVP-16053-00 HTVP-16069-00
HTVP-16029-00
HTVP-16030-00 HTVP-16050-00 HTVP-16067-00
HTVP-16051-00 HTVP-16068-00

HTVP-16066-00 INSTRUCTIO

HTVP-16066-00
HTVP-16047-00 HTVP-16075-00 INSTRUCTION MANUAL
HTVP-16048-00
HTVP-16049-00 HTVP-16075-00 REPORT

HTVP-16045-00 HTVP-16075-00
HTVP-16046-00
HTVP-16070-00
HTVP-16062-00 HTVP-16071-00
HTVP-16063-00
HTVP-16069-00
HTVP-16059-00

HTVP-16057-00

HTVP-16054-00
HTVP-16055-00
HTVP-16056-00

HTVP-16069-00 INSTRUCTION MANUAL

HTVP-16069-00

HTVP-16067-00
HTVP-16068-00

HTVP-16066-00 INSTRUCTION MANUAL

HTVP-16066-00