Short

DIOVS for ReSTOR Aspheric +3.0 Add Power IOL

Long
Design Input, Output, and Verification Summary for ReSTOR Aspheric
Power IOL
1. CHANGE(S) FROM
Proce
Section Chang Changes/
and (YN)
5.4. N Revised Government Relations
indicate NTIOL status will
Table N Clarified that
specification applies to the
Table N Updated TSE
Table N Reference standard for acetone residuals
ISO
Table N Removed reference to EN ISO
Tables 5.5.1 N Added overall process validation
RPT, reference to EN ISO
updated standards, as
Table N Updated
2. PURPOSE
The purpose of this document is to describe the design input, output and
for the AcrySof® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens

3. SCOPE
The design inputs define the AcrySof® ReSTORnAspheric +3.0 D Add Power
SN6AD1 in terms of required and requested attributes. The design outputs
specifications necessary to realize the design input attributes. These include
specifications, in-process target dimensions, as well as material, optical,
chemical, biological, packaging, labeling, shelf life, and shipping and handling
The design verification includes applicable reports and references that
performance. This summary addresses the design input, output and verification
elements of EN ISO 13485, EN ISO 9001, FDA requirements, and Alcon

4. RESPONSIBILITIES
Surgical IOL Development is responsible for maintaining this document and
Design Input, Output and Verification Summary. Other functional areas are responsible for
supporting documentation, e.g., Toxicology, Chemistry, and Process
This document shall be endorsed as required in IOL R&D SOP

5. PROCEDURE

5.1. Product Description and

The AcrySof® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 is
chamber lens intended as an optical implant designed to replace the human crystalline
adult patients. The lens is designed to provide a range of functional vision from
near. The lens design also incorporates an aspheric anterior surface to
spherical aberration of the human eye. The lens is implanted into the capsular
human crystalline lens

Each lens has an optical portion and mechanical support elements (haptics) composed
same AcrySof Natural (AL-37884) IOL material used for other CE marked and
approved AcrySof Natural single-piece IOL models. The AcrySof Natural IOL material
flexible acrylate / methacrylate copolymer containing 0.04% covalently
polymerizable dye identified as AL-8739. The AL-8739 material is added to filter light
violet and blue light regions, 400 to 500 rim. The flexible material allows the lens
folded in such a manner to allow insertion through an incision smaller than the
of the lens. After surgical insertion into the eye, the lens gently unfolds to restore
performance. The optical portion is a biconvex optic containing an
diffractive structure that divides incoming light to provide a range of functional
distance to near. Mechanical support elements (haptics) provide proper positioning
lens optic within the capsular bag. The lens is supplied sterile with the lens
within a pouch and packaged in a protective box (also containing labels
information). Sterilization is performed using an ethylene oxide

5.1.1. DESCRIPTION OF

5.1.1.
The AcrySot® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 will
in a standard Alcon IOL outer box. Inside will be a standard polyester / Tyvek®
and inside of the pouch will be a wagon wheel lens case containing
5.1.1.
The outer box should be opened in the operating room by a technician or nurse. The
technician or nurse then opens the pouch revealing the wagon wheel case. The sterile
surgeon will receive the wagon wheel case and bring it into the

5.1.1.
The sterile nurse or surgeon repositions the wagon wheel case with the top lid facing
twists the lid off the lens case exposing the

5.1.1.
The sterile nurse or surgeon then removes the lens from the wagon wheel case
Alcon forceps (or

5.1.1.
The lens is then folded, or placed into the delivery system, and surgically inserted as
foldable posterior

5.1.1.
The box, pouch, and wagon wheel case can be discarded in a manner following
guidelines for non-

5.1.2. I D E N T I F I C AT I O N OF PRODUCT ENVIRONMENTS

5.1.2.
This medical device will be subjected to ambient conditions during storage and
ranging from -18° C to 45° C. Environmental conditions are defined in ISO
ASTM D4169. [Refer to

5.1.2.
The product is implanted in the human eye (aqueous environment) with a typical
of 35° C ± 2° C. [Refer to

5.1.2.
The product may be exposed to viscoelastic and BSS® irrigating solutions
temperature during surgical procedures. [Refer to

5.1.2.
The product may be implanted by either sterile Alcon forceps (or equivalent)
folder/delivery system. [Refer to Tables 5.5.8.

Printed By: James Poirier P r i n t Date: 05/06/2008 08:11:33

5.1.3. K E Y M A N U FA C T U R I N G TECHNOLOGIES

5.1.3.
Fourth Order Spherical Aberration will be verified by measuring the
using a Hartman-Shack wavefront sensor. [Refer to

5.1.3.
Image quality will be verified using MTF. Product release criteria will be the same as for
current ReSTOR lenses. [Refer to Tables 5.5.1.

5.1.3.
Sterilization to be performed using an ethylene oxide based process. [Refer to

5.2. Required

5.2.1. P H Y S I C A L , M AT E R I A L , ANDE PERFORMANCE REQUIREMENTS

5.2.1.1. PHYSICAL

5.2.1.1.
The lens should be 13.0 mm in overall diameter (length) to support the lens in
bag. [Refer to Tables 5.5.1.

5.2.1.1.
The clear optic diameter should be 6.0 mm. [Refer to Tables 5.5.1.

5.2.1.1.
Optic edge thickness should be similar to other single-piece models; with lower
12.0 D) having a 0.30-mm edge, and higher diopter lenses (> 12.0 D) having a
edge. [Refer to Tables 5.5.1.

5.2.1.1.
The lens is a single-piece lens with two open loop haptics designed to center the
the bag. The shape of the haptics should be equivalent to other single-piece
models. [Refer to Tables 5.5.1.

5.2.1.1.
The geometry of the haptics should be equivalent to other single-piece AcrySof®
0.43-mm for thickness in the region from 0 7.5 mm to the periphery of the haptics,

Printed By: James Poirier P r i n t Date: 05/06/2008

width at the minimum point, and 0.73 mm width at the maximum point of the haptic. [Refer
to Tables 5.5.1.

5.2.1.1.
The optic should be aspheric biconvex with a 9 zone apodized diffractive structure
central 3.6 mm of the anterior surface and an aspheric refractive region extending
periphery of the optic. [Refer to

5.2.1.1.
The lens has an anterior aspheric surface to reduce the spherical aberration of the
[Refer to

5.2.1.2. MATERIAL

5.2.1.2.
ACRYSOF®Natural JUL material, AL-37884, for both optic and haptics. [Refer
5.5.1., 5.5.3.

5.2.1.2.
No microvacuoles shall be present in this material per prescribed product
methods. [Refer to

5.2.1.3. PERFORMANCE

5.2.1.3.
The distance power range is to be 10.0 to 30.0 diopters in 0.5 diopter increments, and
34.0 in 1.0 diopter increments. [Refer to Tables 5.5.1.

5.2.1.3.
The near vision add power is to be +3.0 diopters. [Refer to

5.2.1.3.
The Resolution Efficiency of this lens is to be no less than 60% of the
spatial frequency per EN ISO 11979-2. [Refer to

5.2.1.3.
The MTF of this lens is to be as required in the FDA Guidelines for
(5/29/1997) and should be equivalent to other AcrySof® ReSTOR® IOLs. [Refer
5.5.1. and

Printed By: James Poirier P r i n t Date: 05/06/2008

ALCON - Confidential Specification - Design E f f e c t i v e Date: 30-
Document: Version: ,
Status: Effective Page 6

5.2.1.3.
Lens must be qualified with approved Alcon IOL injection systems which provide
to deliver the lens through a small incision without impacting lens performance.
Table

5.2.1.3.
The lens must meet biological, optical, mechanical, and clinical performance
specified in ISO 11979 series and FDA Guidelines for Multifocal IOLs (5/29/1997).
Tables 5.5.4., 5.5.5., 5.5.6.

5.2.1.3.
To verify the asphere on this lens, the 4th Order Spherical Aberration will be
measuring the transmitted wavefront using a Hartman-Shack wavefront sensor.
Table

5.2.2. AESTHETIC AND ERGONOMIC REQUIREMENTS

5.2.2.
Ease and safety of implantation will be similar to JUL Model 5A60D3. [Refer
5.5.9

5.2.2.
Easily removed from packaging within typical operating room/surgical [Refer
Table

5.2.3. USER SAFETY REQUIREMENTS

5.2.3.
Handle with care. The AcrySof® ReSTOR® Aspheric +3.0 D Add Power IOL is
product. [Refer to Tables 5.5.8

5.2.3.
Observe appropriate product insert information regarding indications,
proper use of the product. [Refer to

5.2.3.
A high level of surgical skill is required to implant an intraocular lens. [Refer to
and

Printed By: James Poirier P r i n t Date: 05/06/2008

ALCON - Confidential Specification - Design E f f e c t i v e Date:
Document: PROC-0004206 Version: ,
Status: Effective Page 7

5.2.4. L A B E L I N G , PACKAGING, STORAGE, H A N D L I N G , AND D E L I V E RY REQUIREMENTS

5.2.4.
The lens should be packaged in a wagon wheel case. [Refer to

5.2.4.
The lens should be supplied dry, in an individual package sterilized with
[Refer to

5.2.4.
Shelf life up to 5 years. [Refer to

5.2.4.
The lens must be protected during shipment. [Refer to

5.2.4.
An Alcon qualified delivery system should be used to deliver the lens into the
[Refer to Tables 5.5.8

5.2.4.
The AcrySof® ReSTOR® Aspheric +3.0 D Add Power IOL outer box must be labeled
following information: posterior chamber lens, overall length, optic diameter,
add power, A-constant, sterile, and single-use only. [Refer to

5.2.4.
Lens should be packaged in a branded ReSTOR® Aspheric lens carton or plain
as necessary, along with standard IOL packaging components (e.g. directions for
patient ID card, implant reply card, etc.). [Refer to

5.2.5. M A I N T E N A N C E OR REUSE REQUIREMENTS (OPTIONAL)

5.2.5.1. MAINTENANCE
Non

5.2.5.2. REUSE
The JUL is a single-use only device. [Refer to

5.2.6. ESTIMATES FOR PRODUCT COST (OPTIONAL)

N/A

Printed By: James Poirier P r i n t Date: 05/06/2008

ALCON - Confidential Specification - Design E f f e c t i v e Date: 30-
Document: PROC-0004206 Version: , CURRENT, 3.0
Status: Effective Page 8

5.2.7. SPECIAL
Non

5.3. Requested

5.3.
Expanded diopter range to cover the range from 6.0 to

5.3.
Lens powers > 30.0 diopters available in 0.5 diopter

5.4. Product

5.4.1. P R O D U C T O B J E C T I V E

The objective of the AcrySof® ReSTOR® Aspheric +3.0 D Add Power IOL
is to provide surgeons a foldable single-piece posterior chamber lens intended as
implant designed to replace the human crystalline lens in adult patients to provide a range of
functional vision from distance

5.4.2. P R O D U C T DESCRIPTION

The required product attributes listed in section 5.2 were incorporated to produce
described in tables 5.5.1 — 5.5.9. Key IOL dimensional, physical, and material
are listed in tables 5.5.1 — 5.5.7. Packaging and labeling requirements are contained
5.5.8. Table 5.5.9 lists requirements for shelf-life, shipping,

5.4.3. C L I N I C A L USE AND PERFORMANCE REQUIREMENTS

The AcrySof® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 can
and implanted into the capsular bag using a Monarch I I "B" cartridge or Monarch® II "C"
cartridge following lens extraction. A qualified delivery system is recommended for
implant the lens into the capsular bag utilizing the surgeons

5.4.4. P R O D U C T PA C K A G I N G S U M M A RY

The lens is supplied dry and individually packaged in a wagon wheel lens case.
wheel lens case is composed of two polypropylene components (Cap and Base),
the lens during shipping. The packaged lens is sealed within a polyester / Tyvek
then sterilized using an ethylene oxide based process. The sealed sterile pouch is
into a cardboard protective box. The protective box, which is also containing
product infaunation, is over wrapped with a polypropylene film.

Printed By: James Poirier P r i n t Date: 05/06/2008

ALCON - Confidential Specification - Design E f f e c t i v e Date: 30-
Document: PROC-0004206 Version: , CURRENT, 3.0
Status: Effective Page 9

5.4.5. S TO R A G E AND H A N D L I N G S U M M A RY

The polyester / Tyvek pouch is opened in a sterile area of the operating

temperatures should not exceed 45° C (113° F). Only sterile intraocular
such as BSS® or BSS PLUS® should be used to rinse and/or soak lenses. The lens
exposed to viscoelastic at room temperature during surgical procedures. Careful handling of
the lens is required to avoid damage to lens surface

5.4.6. G O V E R N M E N T RELATIONS S U M M A RY

AcrySof® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 will fall
ReSTOR® IOL ruling regarding presbyopic correcting IOLs. Optical testing
performed to apply for inclusion in the NTIOL class for IOLs that reduce spherical

Printed By: James Poirier P r i n t Date: 05/06/2008 08: 1

P

5.5. Product Release

t
5.5.1. Product Release Specifications and
Desig Referenc Test
Input Descriptio Specification Documen Method /
Dimension

77.M1973
PROC-000182
5.2.1.1. Lens Single- 77.11973
SOP-665-
4201-081
Biconvex aspheric optic with
77.M1973
apodized diffractive PROC-000182
5.2.1.1. Optic 77.11973
located on the SOP-665-
4201-081
surfac
EN ISO
ANSI/OLA
PROC-000182
5.2.1.1. Overall 13.0± 77.M1973
SOP-665-
77.11973
4201-081
EN ISO
ANSI/OLA
PROC-000182
5.2.1.1. Clear Optic 6.0 = 77.M1973
SOP-665-
77.11973
4201-081
77.11973
77.81973
0.30 ± 0.05 mm (10.0 to 12.0 D) 77.81971 PROC-000182
5.2.1.1. Optic Edge
0.21 ± 0.05 mm (12.5 to 34.0 D) 4201-081 SOP-665-
T-096
T-096
IM

5.5.1. Product Release Specifications and Verification Summary -

Desig Referenc Tes
Input Description Specification Documen Method / V
77.11973
77.81973
77.81971 PROC-000182
5.2.1.1. Haptic 0.43 ±
4201-081 SOP-665-
T-096
T-096
77.11973
0.42 ± 0.1 mm (min. pt.) 77.81972 PROC-000182
5.2.1.1. Haptic
0.73 ± 0.1 mm (max. pt.) 4201-081 SOP-665-
T-096
77.11973
77.81972 PROC-000182
5.2.1.1. Haptic Shape profile ±
4201-081 SOP-665-
T-096
Optical
Power (D) To l e r a n c e
EN ISO PROC-000182
10.0 to 15.0 + 0.3
ANSI/OLA 77.R1973
5.2.1.3. Distance 15.5 to 25.0 + 0.4
ANSI Z80.12 Draft SOP-519-
25.5 to 30.0 ± 0.5
(04/02/02 CD1102
31.0 to 34.0 + 1.0

PROC-000182
5.2.1.3. Near (Add) 3.0 ± 0.25 D N/A
SOP-519-

MTF (In wet > 0.43, 3.0 mm

5.1.3. FDA Guidelines PROC-000400
25%-50% spatial ± 0.20, 3.0 mm
5.2.1.3. Multifocal IOL SOP-7304\
k =550 > 0.38, 4.5 mm
JP

5.5.1. Product Release Specifications and Verification Summary —

Desig Referenc Tes
Input Descriptio Specification Documen Method /
Z42 ± 10% of nominal at
4th Order
aperture per 77.R19741 /
5.1.3. Aberration
CD1103 77.R1974 PROC-000396
5.2.1.1. Hartman-Shack
Z42 ± 10% of nominal at CD1103 SOP-760-
5.2.1.3. sensor (Z42 in
aperture per 77.R19741 /
Instrumen
CD1103
Resolution efficiency > 60% of
the diffraction limited cut-off EN ISO PROC-000182
5.2.1.3. Resolution
spatial frequency ANSI/OLA SOP-519-
primary
Cosmeti
Microscopic inspection
Surface and Bulk magnification EN ISO PROC-000183
5.2.1.3.
Homogeneit requirements defined in ANSI/OLA SOP-732-
SOP-732-

No microvacuoles after SOP-176-

5.2.1.2. Microvacuole N/A
in 37 ± SOP-592-

Biologic

USP 30
5.1.3. Bacterial <0.5 EU / lens
ANSI/AAMI/ST72 SOP-308-
5.2.4. (Pyroge Endotoxi
EN ISO
USP 30
EN
EN
5.1.3. USP SOP-317-
Sterility Assurance SAL_
5.2.4. Indicators SOP-529-ST
ISO
ANSI/OLA
EN ISO
IP

5.5.1. Product Release Specifications and Verification Summary—

Desig Referenc Tes
Input Descriptio Specification Documen Method / V
Ethylene Oxide
Federal
Vol. 43,
5.1.3. SOP-319-
Ethylene 25 ppm (5_ 1.25 EN ISO
5.2.4. SOP-667-
ISO
ANSI/OLA
Federal
Vol. 43,
5.1.3.
Ethylene _.25 ppm 2 . 0 !Lig liens) EN ISO SOP-318-
5.2.4.
ISO
ANSUOLA
Optic and Haptic Material —ACRYSOF NATURAL IOL Material —

EN ISO
UV/Visible Light PROC-000323
5.2.1.2. Max. trans. 8 5 % at ANSI/OLA
Transmissio SOP-349-
PROC-000389

EN ISO
Cut-off 3 9 0 nm PROC-000323
5.2.1.2. UV Cut-Off ANSI/OLA
transmissio SOP-349-
PROC-000389

1.5550 ± 0.0007 @25°

Sodium D-Light (1.5542 ± PROC-000197
5.2.1.2. Refractive PROC-000389
0.0007 @ 37° SOP-359-
7=550

Matches Standard PROC-000197

5.2.1.2. Infrared PROC-000389
(AL-37884 SOP-597-LS
lP

5.5.2: In-Process Target Dimensions and

Desig Referenc Tes
Inpu Descriptio Specificati Docume Method /
Mechanical—Pre-
EN ISO
ANSI/OLA PROC-000185
5.2.1.1. Overall 13.14 ± T-089 SOP-652-
4201-081 SOP-751-
T-096
EN ISO
ANSI/OLA PROC-000185
5.2.1.1. Optic 6.07 ± T-089 SOP-652-
4201-081 SOP-751-
T-096
77.81973
77.81971
0.30 ± 0.05 mm (10.0 to 12.0 D)
5.2.1.1. Optic Edge 4201-081 SOP-653-
0.21 ± 0.05 mm (12.5 to 34.0 D)
T-096
T-096
77.81973
77.81971
5.2.1.1. Haptic 0.43 ± 4201-081 SOP-653-
T-096
T-096
T-089
0.43 ± 0.1 mm SOP-652-
5.2.1.1. Haptic 4201-081
0.74 ± 0.1 mm SOP-751-
T-096

T-089
5.2.1.1. SOP-652-
Haptic Shape profile ± 4201-081
SOP-751-
T-096
P
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5.5.3 Material Properties and

Desig Referenc Tes
Input Descriptio Specificatio Documen Method /
Optic Material - (ACRYSOF NATURAL IOL material —
Ultimate Elongation Mean ultimate
5.2.1.2. NA PROC-00019
at 200
Tensile Strength in
5.2.1.2. Mean strength .. NA PROC-00019
23°
Young's modulus Mean modulus
5.2.1.2. NA PROC-00019
23° 7.0
ISO/FDIS
ME E A/410/01
Raw materials shall
MEDDEV2.11/1,
components of
5.2.1.2. TSE OTEU 2004/ PROC-00010
greater than Category
Commission
detectable infectivity.
2003/32/
CPMP/
Haptic Material - (ACRYSOF NATURAL IOL material —
Ultimate Elongation Mean ultimate
5.2.1.2. NA PROC-00019
at 200
Tensile Strength in
5.2.1.2. Mean strength NA PROC-00019
23°
Young's modulus in air Mean modulus
5.2.1.2. NA PROC-00019
23° .-S7.0
ISO/FDIS
EMEA/
Raw materials shall
MEDDEV2.11/1,
components of
5.2.1.2. TSE 0.IEU 2004/ PROC-00010
greater than Category
Commission
detectable infectivity.
2003/32/
CPMP/
aTR's completed for previous products of same material (AcrySof Natural) and
P
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5.5.4. Optical Requirements and

Desig Referenc Tes
Inpu Descriptio Specificati Docume Method / V
Generate MTF curves at FDA Guidelines
Multifocal
5.1.3. and 5 mm apertures (05/29/9 TR
5.2.1.3. On-axis MTF image plane with the IOL EN ISO PROC-00019
5.2.1.3. on-axis. EN ISO
acceptance ANSI/OLA
Generate MTF curves at
5.1.3. and 5 mm apertures FDA Guidelines
Multifocal TR
5.2.1.3. Decentered MTF image plane with the IOL (05/29/9 PROC-00019
5.2.1.3. decentered up to 1.0 mm. (No EN ISO
specific acceptance
Generate MTF curves at
FDA Guidelines
5.1.3. and 5 mm apertures Multifocal TR
5.2.1.3. Tilted MTF image plane with the IOL (05/29/9 PROC-00019
5.2.1.3. 5° tilt off plane. EN ISO
acceptance
Generate MTF data at
5.1.3. 50, 67.2, 82.8, 100 1p / mm FDA Guidelines
Through-Focus- TR
5.2.1.3. mm in an eye model Multifocal
MTF (05/29/9 PROC-00019
5.2.1.3. cell. (No specific
criteria
EN ISO
Dioptric power within ± 0.25 D ANSI/OLA PROC-000182
5.2.1.3. Astigmatis
limit ANSI Z80.12 SOP-519-
(04/02/02
EN ISO
Implanted through ANSI/OLA
5.2.1.3. PROC-00019
Delivery incision without ANSI Z80.12 Draft
5.2.1.3. PROC-000197
performan (04/02/02
TR
O.
£ .

5.5.5. Mechanical Requirements and

Desig Referenc Tes
Input Description Specificatio Documen Method / Protocol
> 0.08 mN and <
EN ISO
In Vitro Measurement of Meets the requirements
5.2.1.3. ANSI/OLA PROC-00019
Haptic Compression Level A modification to
ISO/TR
Model
Axial displacement <
In Vitro Axial in anterior or EN ISO
5.2.1.3. PROC-00033
in while JUL is compressed ANSI/OLA
diameter of
Sum of mean optic
In Vitro Optic and 2 standard deviations 1 0 EN ISO
5.2.1.3. PROC-00019
Due To % of the clear optic (_.. ANSI/OLA
when compressed to
Sum of mean optic tilt
In Vitro Optic Tilt Due To standard deviations < EN ISO
5.2.1.3. PROC-00019
Compressio when compressed to 10.0 ANSI/OLA
35 ± 2°C
Haptic Contact Angle
degrees when
EN ISO
compressed to 10 mm
5.2.1.3. In Vitro Haptic ANSI/OLA PROC-00019
the requirements for a Level A
ISO/TR
modification to a
JUL
> 0.08 mN and <
EN ISO
In Vitro Compression Meets the requirements
5.2.1.3. ANSI/OLA PROC-00019
Decay And Level A modification to
ISO/TR
Model
No micro-cracks
20X following 250,000 EN ISO
5.2.1.3. Dynamic Fatigue Durability PROC-00019
± 0.25 mm displacement ANSI/OLA
10 mm compressed
1£

5.5.5. Mechanical Requirements and Verification Summary —

Desig Referenc Tes
Input Descriptio Specificatio Documen Method / Protocol
EN ISO
5.2.1.3. Haptic > 0.25 N PROC-00019
ANSI/OLA
P
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5.5.6. Physical and Chemical Requirements and

Desig Referenc
Input Descriptio Specificatio Documen Test Method / Protoc
When examines by light
Extractable microscopy (10X), SEM
and UV/Vis
(Polymerization extracted material shall
and Contact differences in
appearance of UV/
Key Formulation indicative of material
ar Extractable content
evaluated to assess PROC-000052
5.2.1.3. • 2-Phenylethy EN ISO PROC-00005
• 2-Phenylthy introduced by toxic
PROC-00039
from processing and
• ortho-methallyl
the use or aging of
• 1,4-Butanedio
material. Lens
• Perkadox from the ACRYSOF
product formulation should
butylcyclohexano extractable content
• A L -8739 or less than that for
AcrySof® lens (MA60BM).
No evidence of hydrolysis Method
material to cause changes in MD8901,
5.2.1.3. Hydrolytic surface appearance EN ISO MD8902A
potentially PROC-00005
chemical PROC-00039
Damage similar or less in
that of silicone or PMMA IOLs.
Method defined in
No change in
5.2.1.3. Nd:YAG Laser No detectable monomer or UV 025:36820:1192
EN ISO
protocols
chromophore in
N-99-04
non-cytotoxic in
tests after YAG laser
aTR's completed for previous products of same material and
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5.5.6. Physical and Chemical Requirements and Verifications Summary —

Desig Referenc Tes
Input Descriptio Specificatio Documen Method / V
No significant change in light
transmission
and after the Test methods
5.2.1.3. UV EN ISO
leaching in
No significant change
quality
Typical value:
5.2.1.2. Glass Transition 77.B1896 PROC-00013
measured by DSC at
5.2.1.2. Not more than 5 USP 30
Heavy Metals EN ISO
5.2.1.3. metals Method II
Manufacturing Contact Material Residual

5.2.1.2. Acetone Less than EN ISO SOP-600-

TR's completed for previous products of same material and

P
J

5.5.7. Biological Requirements and

Desig Referenc Tes
Input Descriptio Specificatio Documen Method /
in vitro Cytotoxicitya _
EN ISO
5.2.1.3. Cytotoxicity Non- EN ISO N-97-17
EN ISO
EN ISO
5.2.1.3. Cytotoxicity— Non- EN ISO N-97-17
EN ISO
Cytotoxicity—
5.2.1.3. Non- EN ISO N-99-03
(extract
Genotoxicity/
EN ISO
5.2.1.3. Bacterial Reverse Non- EN ISO N-97-08
EN ISO
EN ISO
5.2.1.3. Chromosome Non- EN ISO N-00-08
EN ISO
Irritation Sensitizatio
EN ISO
5.2.1.3. Guinea Pig Non- EN ISO N-97-19
EN ISO
Local Effects After Implantation
EN ISO
5.2.1.3. Muscle Non- EN ISO N-97-19
ISO
EN ISO
5.2.1.3. 6-month Intraocular Non-toxic to EN ISO N-96-27
ISO
TR's completed for previous products of same material and
.
P

5.5.8. Packaging and Labeling Requirements and

Desig Referenc Tes
Inpu Descriptio Specificati Docume Method / V
EN
EN ISO PROC-000176
5.2.4. Sterilization Matches ISO SOP-183-
5203-005 10-800-92
10-800-07
EN ISO PROC-000176
Meets specifications defined in
5.2.4. Wagon 5403-018 SOP-183-
10-800-916, Base and cap
10-800-91 10-800-91
Matches approved
5.2.4. Lens EN ISO NA
file
EN
EN ISO
PROC-000176
Matches approved ISO
5.2.4. Mylar Case SOP-183-
file 5203-012
10-500-10
10-500-1
SN6ADLPRI
EN
EN ISO
PROC-000176
5.2.4. Matches approved EN ISO
Lens SOP-185-
5.2.4. file ISO
10-800-92
5203-008
5203-022
5.1.2. PROC-000176
5.2.3. EN SOP-185-
Product Information Matches approved L
5.2.3. EN ISO 11979-4 FDA 10-500-9
(DFU file
5.2.4. ISO 40-500-092
5.2.4. 40-500-090 (EU)
P
l

5.5.8. Packaging and Labeling Requirements and Verification Summary —

Desig Referenc Tes
Inpu Descriptio Specificati Docume Method / V
EN ISO
Matches approved PROC-000176
5.2.4. Implant 5203-011
fil SOP-185-
10-500-05
PROC-000176
EN ISO
Matches approved SOP-185-
5.2.4. Patient 5203-014
fil 40-500-00
5203-022
40-500-08
EN
EN ISO
PROC-000176
5.2.4. Box Label Matches approved ISO L
SOP-185-
5.2.5. Chamb file 5203-005
10-500-09
SN6AD1.SE
SN6AD1.SEC.E
dP

5.5.9. Shelf-Life, Shipping and Handling Requirements and

Desig Referenc Tes
Inpu Descriptio Specificati Docume Method /
ISO
5.2.4. Shelf Five-year N-96-07
EN
Shipping
EN ISO
Shippi ISO
5.2.4. 1, 2, 4, 8, 16, 33, 48, 128 cartons CD0148
Configuratio EN
ASTM
EN ISO
Allowable No cosmetic defects to lens @ 16X. No ISO Method defined in
5.2.4.
Damag visible pouch or EN 001:36820:01
ASTM
EN ISO
Storag Do not store lenses at temperatures over ISO Method
5.1.2.
Requireme or below EN 001:36820:01
ASTM
• O p e n Tyvek®/Mylar pouch in
area of the
• O p e n the wagon
• Remove the lens using
forcep
5.1.2.
• U s e only a sterile
5.1.2.
solution, such as BSS® or BSS
5.1.2.
rinse and/or 40-500-092
5.2.2. Handlin N/A
• H a n d l e lenses carefully to 40-500-090 (EU)
5.2.3.
to lens surfaces
5.2.3.
5.2.4. • I m p l a n t the lens into the eye as
foldable, posterior
• A high level of skill is
intraocular lens
• R e m o v e viscoelastic from the eye
close of
!
£

5.5.9. Shelf-Life, Shipping and Handling Requirements and Verification Summary —

Desig Referenc Tes
Inpu Descriptio Specificati Docume Method /
EN ISO
Surgical Procedure will be no
5.2.2. Surgical EN ISO N/A
than that for SA60D3 IOL's.
EN ISO
ALCON - Confidential Specification Effective Date:ftgota62029
Document: PROC-0004206 Version: , CURRENT, 3.0
Status: Effective

5.6. Standards

All requirements of the following standards shall

Publish
Numbe Titl Subje
Dat
21 CFR U.S. Food and Drug Administration 4/1/200 Regulatio
Device
21 CFR U.S. Food and Drug Administration 4/1/200 Regulatio
Regulatio
ANSI/AAMI Bacterial Endotoxins—Test 9/10/20 Biologic
Routine Monitoring, & Alternatives
ANSI American National Standard for 9/20/20 Optic
Intraocular
ANSI American National Standard (DRAFT) 4/2/200 Regulatio
Multifocal Intraocular
ASTM Standard Practice for Performance Testing of 10/1/20 Packagi
Shipping Containers
Commission Commission Directive 4/23/20 Biologic
2003/32/ specifications as regards the requirements
in Council Directive 93/42/EEC with
medical devices manufactured utilizing tissues of
animal origin—Text with
CPMP/ Position paper on production of tallow 12/17/19 Biologic
for use in
EMEA/ Note for the Guidance on Minimizing the Risk of 200 Biologic
Transmitting Animal Spongiform
Agents via Human &Veterinary
EN Sterilization of Medical Devices — 1/1/19 Sterilizati
Routine Control of Ethylene Oxide
EN Sterilization of Medical Devices— 12/11/20 Sterilizati
Medical Devices to be labeled

EN Graphical Symbols for Use in labeling 8/13/20 Labelin

Device
EN Terminology, Symbols, and 7/15/19 Regulatio
with Medical Devices: Information Supplied
manufacturer with
ISO/FDIS Animal Tissues in Manufacturing 200 Biologic
(Part 1, 2, Devices-Part 1, 2,
EN Ophthalmic Implants-Intraocular Lenses 11/29/20 Packagi
Shelf-life and
EN ISO Quality Management Systems— 12/15/20 Regulatio

Printed By: James Poirier P r i n t Date 05/06/2008 08:11:33

ALCON - Confidential Specification Effective Date:
Document: Version: ,
Status:

Publishe
Numbe Title Subjec
Dat
EN ISO Biological Evaluation of Medical Devices 10/9/20 Biologic
Guidance on selection
EN ISO Biological Evaluation of Medical Devices - 10/31/20 Biologic
Tests for genotoxicity,
reproductive
EN ISO Biological Evaluation of Medical Devices 9/15/19 Biologic
Tests for in vitro
EN ISO Biological Evaluation of Medical Devices 1/1/19 Biologic
Ethylene oxide
EN ISO Biological Evaluation of Medical Devices 10/8/20 Biologic
Tests for irritation and
EN ISO Biological Evaluation of Medical Devices 9/29/20 Biologic
Tests for systemic
EN ISO Packaging for terminally 5/31/20 Packagin
Devices Part 1: Requirements for
Barrier Systems and
Part 2: Validation Requirements for Forming,
Sealing, and Assembly
EN ISO Sterilization of Medical Devices 4/28/200 Sterilizati
Methods Part 1: Determination of a
Microorganisms
EN ISO Ophthalmic Implants—Intraocular Lenses Part 2 5/15/20 Optic
Optical Properties &
EN ISO Ophthalmic implants- intraocular lenses- 5/1/200 Mechanic
Mechanical properties and test methods
Editio
EN ISO Ophthalmic Implants—Intraocular lenses- 9/15/20 Packagi
Labeling &
EN ISO Ophthalmic implants —Intraocular Lenses Part 5 6/30/20 Biologic
Biocompatibilit
EN ISO Ophthalmic implants —Intraocular Lenses Part 7 5/31/20 Clinic
Clinical Investigations—
EN ISO Ophthalmic implants - Part 8— 8/31/20 Optic
Requireme
EN ISO Ophthalmic implants - Part 9 9/1/200 Optic
intraocular
EN ISO Medical Devices Quality Management Systems 7/24/20 Regulatio
Requirements for
EN ISO Clinical Investigation of Medical 3/12/20 Clinic
Human Subjects—Part 1: General
EN ISO Clinical Investigation of Medical 3/12/20 Clinic
Human Subjects—Part 2: Clinical
Plan

Printed By: James Poirier Print Date: 05/06/2008

A L C O N - Confidential Specification Effective Date:114:0082039
Document: PROC-0004206 Version: ,
Status: Effective

Publish
Numbe Titl Subje
Dat
EN ISO Cleanroorns and 8/15/19 Environmen
Environments—Part 1: Classification
Cleanline
EN ISO Cleanrooms and 12/15/20 Environmen
Environments—Part 2: Specifications
and monitoring to prove continued
ISO
EN ISO Medical Devices: Application of 4/30/20 Regulatio
to Medical
FDA Guidelines for FDA Guidelines for Multifocal 5/29/199 Regulatio
Multifocal IDE Studies
EN ISO Quality Assurance Requirements 4/16/20 Measurem
Equipment Part 1: Metrological
System for Measuring
ISO Biological Evaluation of Medical Devices- 4/15/20 Biologic
Tests for Local Effects After
Edition; (CEN EN
ISO Medical Devices—Validation and 1/1/19 Sterilizati
of Ethylene Oxide
ISO Ophthalmic implants - Part 6 - Shelf-Life & 6/1/20 Packagi
Transport
ISO Medical Device Symbols to be Used 4/15/20 Labelin
Device Labels, Labeling, and
Part 1: General Requirements—
ISO TR Ophthalmic Implants—Intraocular lenses 2/1/200 Regulatio
Guidance on assessment of the need
investigation of intraocular
modificatio
MDD 93/42 Council Directive 93/42/EEC for 6/14/19 Regulatio

MEDDEV2.11/1, Guidance document discussing management 4/200 Biologic

in animal tissue where TSE risk
OJEU 2004/ Note for guidance on minimizing the 200 Biologic
transmitting
USP 30 Bacterial Endotoxins 1/1/200 Biologic

USP 30 Sterilization and 1/1/20 Biologic

6. REFERENCES
6.1
PROC-0001786 Design Input, Output and

Printed By: James Poirier P r i n t Date: 05/06/2008

ALCON - Specification - Design E f f e c t i v e Date:fth92429
Document: Version: ,
Status:

6.
PROC-0001766 Procedure for R&D Document

7. APPENDICES
Non

Printed By: James Poirier P r i n t Date: 05/06/2008

ALCON - Confidential Specification - Design E f f e c t i v e Date: 30-
Document: PROC-0004206 Version: ,
Status: Effective

Approval
DIOVS for ReSTOR Aspheric
AddPower IOL Model SN6AD1

Date/
(mm/dd/yyyy GMT): Signed Justificatio

07/25/2007 Chuck Other Tech/

07/25/2007 Michael Other Tech/

07/25/2007 Steve Unit Head

07/26/2007 Steve Other Tech/

07/27/2007 David Other Tech/

07/27/2007 Tim Other Tech/

07/27/2007 James PRO

Printed By: James Poirier P r i n t Date: 05/06/2008