CRYSTALENS ACCOMMODATING IOL

Description of Event or Problem

IT WAS REPORTED THAT THE DAY AFTER IMPLANTATION OF AN INTRAOCULAR LENS INTO THE LEFT EYE, CAPSULAR FIBROSIS WAS OBSERVED. FIVE WEEKS AFTER THE ONSET OF CAPSULAR FIBROSIS, ASYMMETRIC LENS VAULTING WAS OBSERVED, BUT NOT TREATED. IT WAS ALSO REPORTED THAT THE PATIENT HAD DEVELOPED PROGRESSIVELY INCREASING ASTIGMATISM, UP TO 4 DIOPTERS BY 2 MONTHS POST-OP, SECONDARY TO ASYMMETRIC LENS VAULTING. APPROXIMATELY TWO AND A HALF MONTHS AFTER IMPLANTATION OF THE INITIAL IOL, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL DUE TO UNRESOLVED Z-SYNDROME. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS CAPSULAR FIBROSIS.

Additional Manufacturer Narrative

ALTHOUGH REQUESTED, THE LENS WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT FIND ANY NON-CONFORMITIES OR ANOMALIES RELATED TO THIS EVENT. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H2, H3, H6, H11: THE DEVICE WAS RETURNED IN THREE PIECES WITH HALF THE OPTIC MISSING. VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURN. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.