Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia Sheryl Berman, MD Medical Officer FDA/CDRH/ODE/DOED

Questions for Panel Consideration 1. What are the concerns regarding the incidence of induced cylinder with significant axis shift, and its consequent effect on efficacy? 2. Is 12-month follow-up sufficient to provide reasonable assurance of safety and efficacy? There are 21 eyes available at 24 months. Should data for these eyes also be required in the labeling? 3. Does the refractive correction obtained with this device, in light of the rate of change of mean MRSE over time and the incidence of over- and undercorrection, justify the potential risks? 4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels? 5. Do the safety and efficacy data presented in this PMA support approval of this device for the requested indication? Is the requested indication appropriate as worded, based on the study outcome? 6. What are your recommendations for labeling regarding regression of effect, induction of cylinder, and incidence of visual symptoms? Are there additional labeling recommendations?

Question for Panel Consideration 1. What are the concerns regarding the incidence of induced cylinder with significant axis shift, and its consequent effect on efficacy?

Induced Increase in Cylinder Magnitude (% of eyes)

Induced Change in Vector Cylinder Magnitude (% of eyes)

Induced Absolute Axis Shift (% of all treated eyes)

Post-op Cylinder Magnitude (% of eyes) Note: all eyes had baseline cylinder magnitude 0.75D or less

Effect of Induced Cylinder on Uncorrected Visual Acuity (% of eyes at month 12)

Question for Panel Consideration 2. Is 12-month follow-up sufficient to provide reasonable assurance of safety and efficacy? There are 21 eyes available at 24 months. Should data for these eyes also be required in the labeling?

Question for Panel Consideration 3. Does the refractive correction obtained with this device, in light of the rate of change of mean MRSE over time and the incidence of over- and undercorrection, justify the potential risks?

Stability of MRSE 12-month consistent cohort (n=186)

Stability of MRSE cohort with 2 consecutive visits

Accuracy of MRSE

Question for Panel Consideration 4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels?

Visual Symptoms with  5% increase over baseline (% eyes with moderate to severe symptoms)

Question for Panel Consideration 5. Do the safety and efficacy data presented in this PMA support approval of this device for the requested indication? Is the requested indication appropriate as worded, based on the study outcome?

Requested Indication for Use CK treatment for the reduction of spherical hyperopia in the range of: to D of cycloplegic spherical hyperopia D or less of refractive astigmatism to D cycloplegic spherical equivalent In patients with  0.50 D difference between preoperative manifest and cycloplegic refractions In patients 40 years of age or older The magnitude of correction diminishes over time with an average loss of approximately 10% of the intended correction at one year

Question for Panel Consideration 6. What are your recommendations for labeling regarding regression of effect, induction of cylinder, and incidence of visual symptoms? Are there additional labeling recommendations?

Questions for Panel Consideration 1. What are the concerns regarding the incidence of induced cylinder with significant axis shift, and its consequent effect on efficacy? 2. Is 12-month follow-up sufficient to provide reasonable assurance of safety and efficacy? There are 21 eyes available at 24 months. Should data for these eyes also be required in the labeling? 3. Does the refractive correction obtained with this device, in light of the rate of change of mean MRSE over time and the incidence of over- and undercorrection, justify the potential risks? 4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels? 5. Do the safety and efficacy data presented in this PMA support approval of this device for the requested indication? Is the requested indication appropriate as worded, based on the study outcome? 6. What are your recommendations for labeling regarding regression of effect, induction of cylinder, and incidence of visual symptoms? Are there additional labeling recommendations?

Question for Panel Consideration 1. What are the concerns regarding the incidence of induced cylinder with significant axis shift, and its consequent effect on efficacy?

Question for Panel Consideration 2. Is 12-month follow-up sufficient to provide reasonable assurance of safety and efficacy? There are 21 eyes available at 24 months. Should data for these eyes also be required in the labeling?

Question for Panel Consideration 3. Does the refractive correction obtained with this device, in light of the rate of change of mean MRSE over time and the incidence of over- and undercorrection, justify the potential risks?

Question for Panel Consideration 4. Are there concerns regarding the increased incidence of visual symptoms from pre-op levels?

Question for Panel Consideration 5. Do the safety and efficacy data presented in this PMA support approval of this device for the requested indication? Is the requested indication appropriate as worded, based on the study outcome?

Question for Panel Consideration 6. What are your recommendations for labeling regarding regression of effect, induction of cylinder, and incidence of visual symptoms? Are there additional labeling recommendations?