EXPERIENCE WITH THE EXPERIENCE WITH THE LENSTEC KH3500 TETRAFLEX LENSTEC KH3500 TETRAFLEX

LENSLENS

We Compared The Print Sizes We Compared The Print Sizes

On The ETDRS Near Chart To On The ETDRS Near Chart To

Commonly Read Print ObjectsCommonly Read Print Objects

What is Functional Near Acuity?What is Functional Near Acuity?

ETDRS Near ChartETDRS Near Chart

We Couldn’t Find ANY We Couldn’t Find ANY

Commonly Read Print Objects Commonly Read Print Objects

With Print Size Of 20/40 (6/12) With Print Size Of 20/40 (6/12)

Or WorseOr Worse

What is Functional Near Acuity?What is Functional Near Acuity?

Sweetener PacketsSweetener PacketsBetween 20/40 And 20/50 (J5-J6)Between 20/40 And 20/50 (J5-J6)

Want AdsWant Ads20/50 (J6)20/50 (J6)

Stock QuotationsStock Quotations20/50 (J6)20/50 (J6)

Telephone DirectoryTelephone Directory20/63 (J8)20/63 (J8)

Standard Newspaper PrintStandard Newspaper Print20/80 (J9)20/80 (J9)

Journal/ Magazine ArticlesJournal/ Magazine Articles20/80 (J9)20/80 (J9)

TETRAFLEX KH 3500-TETRAFLEX KH 3500-ADVANTAGESADVANTAGES

PolyHEMA – Highly Biocompatible

Large optic – 5.75mm

Injectable – Inserted Thru 1.8mm Cartridge

Standard Phaco Technique – No Learning Curve

Square Edge Design

TetraFlex Intended BenefitsTetraFlex Intended Benefits

To Provide Enhanced Distance and Near Vision with an Increased Independence

from Corrective Lens Wear

International Data Will Be International Data Will Be Compared WithCompared With

1 Month (N = 209) and 6 Month 1 Month (N = 209) and 6 Month (N = 140) Data Obtained From (N = 140) Data Obtained From the U.S. FDA Clinical Trial. the U.S. FDA Clinical Trial.

International Exclusion CriteriaInternational Exclusion Criteria

Any subject with a preoperative Any subject with a preoperative cylinder of >= 2.5 D (Astigmatism)cylinder of >= 2.5 D (Astigmatism)

Any subject requiring corneal Any subject requiring corneal relaxing incisions for treatment of relaxing incisions for treatment of astigmatismastigmatism

Any subject diagnosed with Any subject diagnosed with amblyopia preoperativelyamblyopia preoperatively

INTERNATIONAL DATAINTERNATIONAL DATATETRAFLEX A-IOLTETRAFLEX A-IOL

95 Eyes In 42 Patients95 Eyes In 42 Patients

36 Are Bilaterally Implanted36 Are Bilaterally Implanted

Follow-up at 6 Months or LaterFollow-up at 6 Months or Later

is 81%is 81%

All Eyes- Bilaterally and All Eyes- Bilaterally and Unilaterally ImplantedUnilaterally Implanted

International DataInternational DataUncorrected Distance VisionUncorrected Distance Vision

39 38

51

6772 73

82 85 8288 91 92

99 100 99

0%

20%

40%

60%

80%

100%

20/20 orBetter

20/25 orBetter

20/32 orBetter

20/40 orBetter

20/80 orBetter

1 Month 3 Month 6 Month

US FDA Trial DataUS FDA Trial DataUncorrected Distance Visual Acuity Uncorrected Distance Visual Acuity

52 58

7785 87

95 9298 94

10097

100

0%

20%

40%

60%

80%

100%

20/20 orBetter

20/25 orBetter

20/32 orBetter

20/40 orBetter

20/50 orBetter

20/63 orBetter

1 Month 6 Month

International DataInternational DataUncorrected Near VisionUncorrected Near Vision

7 3 4

2113

9

3425

21

49 46 48

74 71 71

0%

20%

40%

60%

80%

100%

20/20 orBetter

20/25 orBetter

20/32 orBetter

20/40 orBetter

20/80 orBetter

1 Month 3 Month 6 Month

5 2

156

28

19

4539

6659

85 83

92 94

0%

20%

40%

60%

80%

100%

20/20 orBetter

20/25 orBetter

20/32 orBetter

20/40 orBetter

20/50 orBetter

20/63 orBetter

20/80 orBetter

1 Month 6 Month

US FDA Trial DataUS FDA Trial DataUncorrected Near Visual Acuity Uncorrected Near Visual Acuity

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Newspaper Newspaper PrintPrint

International Data International Data Distance Corrected Near VisionDistance Corrected Near Vision

1 1 18 6

1219

25 26

4652

63

4652

63 6776

88

67

76

88

0%

20%

40%

60%

80%

100%

20/20 orBetter

20/25 orBetter

20/32 orBetter

20/40 orBetter

20/50 orBetter

20/63 orBetter

20/80 orBetter

1 Month 3 Month 6 Month

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2 15

1

126

3124

53 54

76 73

90 90

0%

20%

40%

60%

80%

100%

20/20 orBetter

20/25 orBetter

20/32 orBetter

20/40 orBetter

20/50 orBetter

20/63 orBetter

20/80 orBetter

1 Month 6 Month

US FDA Trial DataUS FDA Trial Data Distance Corrected Near VisionDistance Corrected Near Vision

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International Data International Data Accommodative AmplitudeAccommodative Amplitude

98 100 100

70 73 76

26 2419

10 6 10%

20%

40%

60%

80%

100%

>=1.0D >=2.0D >=3.0D >=4.0D

1 Month 3 Month 6 Month

US FDA Trial Data US FDA Trial Data Accommodative AmplitudeAccommodative Amplitude

100 100 99 99

5652

30 31

0%

20%

40%

60%

80%

100%

>=1.0D >=2.0D >=3.0D >=4.0D

1 Month 6 Month

Bilateral CasesBilateral Cases(International)(International)

Patients Examined Patients Examined BinocularlyBinocularly

International Data International Data Uncorrected Distance VisionUncorrected Distance Vision

62

72 7482

8893 94 94 93

97 97 96100 100.100

0%

20%

40%

60%

80%

100%

20/20 orBetter

20/25 orBetter

20/32 orBetter

20/40 orBetter

20/80 orBetter

1 Month 3 Month 6 Month

International Data International Data Uncorrected Near VisionUncorrected Near Vision

156

15

46

31 33

6456 63

76 72 74

85 88 85

0%

20%

40%

60%

80%

100%

20/20 orBetter

20/25 orBetter

20/32 orBetter

20/40 orBetter

20/80 orBetter

1 Month 3 Month 6 Month

International Data International Data Distance Corrected Near VisionDistance Corrected Near Vision

3 3 49

1929 28

44

6863

69

89

6369

8981 84

96

0%

20%

40%

60%

80%

100%

20/20 orBetter

20/25 orBetter

20/32 orBetter

20/40 orBetter

20/50 orBetter

20/63 orBetter

1 Month 3 Month 6 Month

International Data International Data Accommodative AmplitudeAccommodative Amplitude

100 100 100

8694 96

38 4146

17 19

4

0%

20%

40%

60%

80%

100%

>=1.0D >=2.0D >=3.0D >=4.0D

1 Month 3 Month 6 Month

SUMMARYSUMMARY

Tetraflex Provides Good Tetraflex Provides Good Distance Distance Vision And Vision And Demonstrates Demonstrates Enhanced Near Enhanced Near VisionVision

Performs Best When Implanted Performs Best When Implanted BilaterallyBilaterally

How Do the Distance How Do the Distance Corrected Near Acuities With Corrected Near Acuities With

the Tetraflex Compare to the Tetraflex Compare to Standard Monofocal IOLs?Standard Monofocal IOLs?

Distance Corrected Near Acuity Distance Corrected Near Acuity 1CU vs. ACRYSOF MA 30*1CU vs. ACRYSOF MA 30*

7%0%

7%0%

30%

0%

40%

7%

57%

7%

0%

20%

40%

60%

80%

100%

20/32 orBetter

20/40 orBetter

20/50 orBetter

20/63 orBetter

20/80 orBetter

1CU ACRYSOF

* From Heatley et. al. AJO 2005, 140:207-13* From Heatley et. al. AJO 2005, 140:207-13

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Distance Corrected Near AcuityDistance Corrected Near Acuity TETRAFLEX vs. 1CU* vs. ACRYSOF MA 30*TETRAFLEX vs. 1CU* vs. ACRYSOF MA 30*

26%

7%0%

63%

7%0%

63%

30%

0%

88%

40%

7%

88%

57%

7%

0%

20%

40%

60%

80%

100%

20/32 orBetter

20/40 orBetter

20/50 orBetter

20/63 orBetter

20/80 orBetter

TETRAFLEX 1CU ACRYSOF

* From Heatley et. al. AJO 2005, 140:207-13* From Heatley et. al. AJO 2005, 140:207-13

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Distance Corrected Near AcuityDistance Corrected Near Acuity TETRAFLEX vs. 1CU* vs. ACRYSOF MA 30*TETRAFLEX vs. 1CU* vs. ACRYSOF MA 30*

* From Heatley et. al. AJO 2005, 140:207-13* From Heatley et. al. AJO 2005, 140:207-13

68%

26%

7%0%

89%

63%

7%0%

89%

63%

30%

0%

96%88%

40%

7%

96%88%

57%

7%

0%

20%

40%

60%

80%

100%

20/32 orBetter

20/40 orBetter

20/50 orBetter

20/63 orBetter

20/80 orBetter

TETRAFLEX (BINOCULAR) TETRAFLEX ICU ACRYSOF

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PrintPrintTelephone Telephone DirectoryDirectory

SUMMARYSUMMARY

The Tetraflex IOL Provides Enhanced The Tetraflex IOL Provides Enhanced

Near Acuity When Compared To Near Acuity When Compared To

Another Accommodative IOL And A Another Accommodative IOL And A

Standard Monofocal IOL. It Allows A Standard Monofocal IOL. It Allows A

Large Majority Of Cases To See Large Majority Of Cases To See

Commonly Read Small Print Type.Commonly Read Small Print Type.