P CrystaLens™ Model AT-45 Multipiece Silicone Posterior Chamber Accommodating IOL

Bernard P. Lepri, OD, MS, MEd Clinical Reviewer FDA/DOED

Information for Question #1

Accommodative Substudies A small subset of five subjects implanted bilaterally with the CrystaLens™ at a single clinical site underwent additional testing in an effort to document the mechanism of action of the CrystaLens™, i.e., accommodation achieved by the forward and backward movement of the lens optic along the axis of the eye. A small subset of five subjects implanted bilaterally with the CrystaLens™ at a single clinical site underwent additional testing in an effort to document the mechanism of action of the CrystaLens™, i.e., accommodation achieved by the forward and backward movement of the lens optic along the axis of the eye.

Testing included: dynamic retinoscopydynamic retinoscopy defocus defocus near point evaluation near point evaluation near vision (DxRx cycloplegia) near vision (DxRx cycloplegia) power mapping (Tracey Wavefront) power mapping (Tracey Wavefront) anterior chamber depth ( A-scan ) (cyclopentolate) / 6% pilocarpine.anterior chamber depth ( A-scan ) (cyclopentolate) / 6% pilocarpine.

Mean(±SD) ∆ ACD In mm 0.56mm(0.39) ∆ ACD In D* 1.01 D (0.70) TraceyAbberrometerAccommodation 0.72 D (0.83) Dynamic Retinoscopy 3.14(0.81) Defocus2.43(0.46) Lagenbacher: 1.0mm = 1.8D Accommodative Substudy Summary (n = 10)

Correlation of Accommodative Studies Abb Vs ACD ∆ (D) Abb. Vs retinoscopy Retinoscopy Vs defocus Abb. Vs defocus- ACD ∆(D) Vs defocus R corr

Question #1 This is the first IOL that proposes accommodation as its mechanism of action. This is the first IOL that proposes accommodation as its mechanism of action. a). Do the effectiveness data support a claim of accommodation? a). Do the effectiveness data support a claim of accommodation? b). What performance issues should be considered both generally and for product labeling?

Information for Question #2 The stability of the CrystaLens hinge was demonstrated by: a). in-vitro dynamic fatigue testing up to 1-year b). an analysis of change Dx MRSE between consecutive examinations c). intermediate visual acuity between consecutive examinations

Stability of MRSE Primary Eyes

∆ MRSE Form 3 to 4 %* (n) %* (n) Form 4 to 5 %* (n) %* (n)   0.50 D95% CI 84.1% (206) 84.1% (206) (79.5%, 88.7%) 85.6% (202) 85.6% (202) (81.1%, 90.1%)   1.00 D 95% CI   1.00 D 95% CI 96.3% (236) 96.3% (236) (94.0%, 98.7%) 96.2% (227) 96.2% (227) (93.7%, 98.6%) Mean SD 95% CI mean, Median  Range   0.52 (-0.09, 0.04) (-0.09, 0.04) to   0.45 (0.08, 0.19) to 2.75

∆ UCVA Form 3 to 4 % (n) % (n) Form 4 to 5 % (n) % (n) Decrease  2 lines ± 1 line Increase  2 lines 6.1% ( 14) 6.1% ( 14) 80.8% (185) 13.1% ( 30) 4.4% ( 10) 4.4% ( 10) 81.1% (185) 14.5% ( 33) 81.1% (185) 14.5% ( 33) Mean  SD 95% CI for mean MedianRange 0.27  1.33 (0.10, 0.44) 0.27  1.33 (0.10, 0.44)0 -3 to 5 -3 to  1.16 (0.14, 0.44) 0.29  1.16 (0.14, 0.44)0 -4 to 3 Stability of Uncorrected Near Visual Acuity (UNVA) US Eyes One-Year Consistent Cohort One-Year Consistent Cohort

Visual Acuity Primary Eyes N = 241N (Missing) = 5 (Missing) = 5 Fellow Eyes N = 127N N = 127N (Missing) = 0 (Missing) = 0 n%n% 20/20 or better 20/25 or better 20/32 or better 20/40 or better /41 to 20/100 Worse than 20/ Intermediate Visual Acuity Through Distance Correction (DCIVA) US Eyes

Question #2 Do you believe that the sponsor has demonstrated the stability of the hinge, and therefore the stability of the accommodative refractive effect? Do you believe that the sponsor has demonstrated the stability of the hinge, and therefore the stability of the accommodative refractive effect?

Question #3 Does the panel recommend any other Does the panel recommend any other modifications to the proposed : modifications to the proposed : a). Physician labeling? b). Patient labeling?

Question # 4 Do the data in PMA P support the proposed indication statement? Do the data in PMA P support the proposed indication statement?

Primary implantation for the visual correction of aphakia in adult patients with cataracts. Primary implantation for the visual correction of aphakia in adult patients with cataracts. Provide improved near, intermediate, and distance vision without spectacles. Provide improved near, intermediate, and distance vision without spectacles. Indications for use: