BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE

Description of Event or Problem

DURING INSERTION OF THE INTRAOCULAR LENS (IOL), THE TRAILING HAPTIC CAUGHT IN THE CARTRIDGE AS IT WAS BEING ADVANCED. THE HAPTIC WAS FREED AND THE LENS WAS SUBSEQUENTLY IMPLANTED IN THE PATIENT¿S EYE. THE HAPTIC WAS FOUND TO BE CRACKED AND DISLOCATED FROM THE CAPSULAR BAG, MIGRATING INTO THE SULCUS. TWO WEEKS POST IMPLANT THE HAPTIC WAS REPOSITIONED BACK INTO THE CAPSULAR BAG. THE LENS REMAINS IMPLANTED.

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE AND CANNOT BE RETURNED. THE INVESTIGATION OF THIS EVENT IS ONGOING AND A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B4, G3, H2, H6 AND H10/11. ALTHOUGH REQUESTED, THE DEVICE WAS NOT RETURNED FOR EVALUATION. AS A LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, THE ASSOCIATED DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED. THE 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 THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED. BAUSCH + LOMB WILL CONTINUE TO MONITOR FOR SIMILAR OCCURRENCES.