AcrySofAcrySof®® ReSTOR ReSTOR®® Apodized Diffractive IOLApodized Diffractive IOL

What is the AcrySofWhat is the AcrySof®® ReSTOR ReSTOR® ®

IOL?IOL?

The AcrySofThe AcrySof®® ReSTORReSTOR®® IOL IOL incorporates an incorporates an apodized diffractive apodized diffractive optic with refraction optic with refraction to achieve a range of to achieve a range of quality vision.quality vision.

Apodized Diffractive OpticApodized Diffractive Optic Precise reduction in Precise reduction in

diffractive step diffractive step heights from center to heights from center to periphery of 3.6 mm periphery of 3.6 mm diameter diffractive diameter diffractive regionregion Steps reduce from 1.3 Steps reduce from 1.3

microns to 0.2 microns – microns to 0.2 microns – precise manufacturingprecise manufacturing

gradual energy blend gradual energy blend between powers between powers

Unique to Unique to AcrySofAcrySof®® ReSTOR ReSTOR® ® IOLIOL

3.6 mm

1.5 mm

1.3 micronstep

Original magnification 80 X

Technology of the AcrySofTechnology of the AcrySof®® ReSTORReSTOR®® IOL in “human” IOL in “human”

termsterms Thickness of a Human Hair = Thickness of a Human Hair =

60 microns60 microns

Thickness of a Red Blood Cell = Thickness of a Red Blood Cell = 7 microns7 microns

Step Height at periphery of the Step Height at periphery of the diffractive portion of the diffractive portion of the AcrySofAcrySof® ReSTOR® IOL = 0.2 ® ReSTOR® IOL = 0.2 micronsmicrons

Anatomy of the Apodized Anatomy of the Apodized Diffractive IOLDiffractive IOL

Step heights decrease peripherally from 1.3 – 0.2 microns

A +4.0 add at lens plane equaling +3.2 at spectacle plane

Central 3.6 mm diffractive structure

Apodized Diffractive IOLApodized Diffractive IOL

1.1. Allocate appropriate Allocate appropriate light energy according light energy according to activity and light to activity and light levelslevels

2.2. Offer a full range of Offer a full range of quality visionquality vision

3.3. Minimize visual Minimize visual disturbancesdisturbances

Utilizes diffractive and refractive optics with diffractive apodization to:

Minimizing Visual Disturbances Minimizing Visual Disturbances Through ApodizationThrough Apodization

Apodization is a gradual Apodization is a gradual reduction or blending of the reduction or blending of the diffractive step heights. diffractive step heights.

Optimally manages light Optimally manages light energy delivered to the energy delivered to the retina because it distributes retina because it distributes the appropriate amount of the appropriate amount of light to near and distant light to near and distant focal points, regardless of focal points, regardless of the lighting situation.the lighting situation.

Designed to improve image Designed to improve image quality while minimizing quality while minimizing visual disturbances.visual disturbances.

from Nikon website

Theoretical Total Energy Balance at 550 nm Theoretical Total Energy Balance at 550 nm for AcrySoffor AcrySof®® ReSTOR ReSTOR®® Apodized Diffractive Apodized Diffractive

OpticOptic

Smaller steps further out directless light to near

Grossly magnified schematic.Larger steps at lens center divide light equally between two images

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

1 2 3 4 5 6

Pupil Diameter (mm)@ 550 nm

Rel

ativ

e En

ergy

Distance FocusNear Focus

Energy increases for distance and near vision as pupil increases

1

10

100

2 3 4 5 6

Pupil Size (mm)

Ligh

t Ene

rgy

Distance

Near

Cone threshold ≈0.01

Spectacle FreedomSpectacle Freedom Overall VisionOverall Vision

80

41

25.8

8

17

51

69.3 69

3 8 4.7

23

0102030405060708090

100

% o

f Sub

ject

s

Never Sometimes AlwaysOverall Spectacle Wear

AcrySof® ReSTOR® IOL (N=339)Array (N=99)Eyeonics (N=128)SA60AT (N=125)

Comparative S&E data

AcrySof® ReSTOR® IOLAcrySof® ReSTOR® IOL

FDA Clinical Study ResultsFDA Clinical Study Results

Strengths of the AcrySofStrengths of the AcrySof®® ReSTORReSTOR®® IOL IOL

High quality uncorrected near and High quality uncorrected near and distance vision with 20/40 or better distance vision with 20/40 or better intermediate vision without intermediate vision without movement of the IOLmovement of the IOL

80% Overall Spectacle Freedom80% Overall Spectacle Freedom Nearly 94% of patients would have Nearly 94% of patients would have

the lens againthe lens again

Distance VA Distance VA Binocular 120-180 Days Postoperative

Mea

n Lo

gMAR

VA

AcrySof® ReSTOR® IOL (n=457) Control (n=157) Uncorrected Best Corrected

20/20

20/15-0.20

0.00

0.20

0.40

0.60

20/25

Near VA Near VA Binocular 120-180 Days Postoperative

20/50

20/40

20/30

20/25

20/20

-0.20-0.100.000.100.200.300.400.500.60

Mea

n Lo

gMAR

VA

Uncorrected Distance Corrected Best Corrected

AcrySof® ReSTOR® IOL (n=457) Control (n=157)

Binocular Defocus Curve -Binocular Defocus Curve -A Full Range of VisionA Full Range of Vision

®

Patient Quality of LifePatient Quality of Life

Overall Spectacle Overall Spectacle FreedomFreedom

80

8

17

69

3

23

0102030405060708090

100

% o

f Sub

ject

s

Never Sometimes AlwaysOverall Spectacle Wear

AcrySof® ReSTOR® IOL (N=339)Monofocal (N=156)

0%

20%

40%

60%

80%

100%

% S

ubje

cts

None A little bit Moderate Considerable Major

AcrySof® ReSTOR® IOL (N=124)

Control (N = 36)

QOL Questionnaire - BinocularQOL Questionnaire - BinocularTo what degree does your vision without glasses limit you to reading labels or prices in supermarkets?

QOL Questionnaire - BinocularQOL Questionnaire - Binocular

0%

20%

40%

60%

80%

100%

% S

ubje

cts

None A little bit Moderate Considerable Major

To what degree does your vision without glasses limit you to doing crafts (i.e., sewing, painting)?

AcrySof® ReSTOR® IOL (N=114)

Control (N = 37)

QOL Questionnaire - BinocularQOL Questionnaire - Binocular

0%

20%

40%

60%

80%

100%

% S

ubje

cts

None A little bit Moderate Considerable Major

To what degree does your vision without glasses limit you to shaving or putting on

makeup?

AcrySof® ReSTOR® IOL (N=119)

Control (N = 36)

9%4%

87%

Visual Disturbances Visual Disturbances 120-180 Days Post-Operative120-180 Days Post-Operative

76%

5%19%

4%2%

94%

2%

97%

1%7%2%

91%

Night Vision Problems

HalosGlare

AcrySof®®

ReSTOR® IOLN=457

MonofocalControlN=156

None/Mild Moderate Severe

21% 5%

74%

Subject SatisfactionSubject Satisfaction

0%10%20%30%40%50%60%70%80%90%

100%

% S

ubje

cts

Form 3 (N = 207)

Form 4 (N = 152)

Form 3A (N = 177)

Form 4A (N = 127)

Would you have the same intraocular lens implanted again?

Yes No

Summary of Summary of AcrySofAcrySof®® ReSTOR ReSTOR®® IOL IOL

Data indicates the AcrySofData indicates the AcrySof®® ReSTOR ReSTOR®® IOL:IOL: Provides excellent near VA without Provides excellent near VA without

compromising distance VAcompromising distance VADistance VA (mean uncorrected of 20/20)Distance VA (mean uncorrected of 20/20)Near VA (mean uncorrected of 20/25=J1)Near VA (mean uncorrected of 20/25=J1)

Increased Spectacle Freedom Increased Spectacle Freedom (80% of patients do not require glasses for (80% of patients do not require glasses for daily activities)daily activities)

Provides High Patient Satisfaction Provides High Patient Satisfaction (Nearly 94% would have the lens again)(Nearly 94% would have the lens again)

Patient SelectionPatient Selection

Patient SelectionPatient SelectionPre-operative ConsiderationsPre-operative Considerations

ConsiderationsConsiderations Patients who no longer desire to wear glassesPatients who no longer desire to wear glasses Age – non-Medicare patientsAge – non-Medicare patients Functional and occupational requirementsFunctional and occupational requirements Degree of general alertnessDegree of general alertness Ocular pathologyOcular pathology Patients visual demandsPatients visual demands Expectation for near vision needsExpectation for near vision needs Qualify for bilateral implants Qualify for bilateral implants

Patient SelectionPatient SelectionPre-operative Exclusion CriteriaPre-operative Exclusion Criteria Subjective ExclusionSubjective Exclusion

Hypercritical patientsHypercritical patients Patients with unrealistic expectationsPatients with unrealistic expectations Occupational night driversOccupational night drivers

Medical ExclusionMedical Exclusion >1.0 D of corneal astigmatism>1.0 D of corneal astigmatism Pre-existing ocular pathologyPre-existing ocular pathology Previous refractive patientsPrevious refractive patients Individuals with a monofocal lensIndividuals with a monofocal lens

Brief Statement for the AcrySof® ReSTOR® IOL

AcrySof® ReSTOR® APODIZED DIFFRACTIVE OPTIC INTRAOCULAR LENS

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

INDICATIONS: The AcrySof® ReSTOR® Apodized Diffractive Optic Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence.  The lens is intended to be placed in the capsular bag.

WARNINGS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Some adverse reactions that have been associated with the implantation of intraocular lenses are: hypopyon, intraocular infection, acute corneal decompensation, macular edema, pupillary block, retinal detachment, and secondary surgical intervention (including but not limited to lens repositioning, biometry error, visual disturbances or patient dissatisfaction). As a result of the multifocality, some visual effects (halos or radial lines around point sources of light at night) may also be expected due to the superposition of focused and unfocused multiple images. A reduction in contrast sensitivity may also be experienced by some patients, especially in low lighting conditions such as driving at night. In order to achieve optimal visual performance with this lens, emmetropia must be targeted. Patients with significant preoperative or expected postoperative astigmatism >1.0D may not achieve optimal visual outcomes. Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions.

PRECAUTIONS: Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions. Clinical studies indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO.

ATTENTION: Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions.

Thank YouThank You