ENVISTA SIMPLIFEYE INJECTOR

Additional Manufacturer Narrative

ALTHOUGH REQUESTED, THE DEVICE WAS NOT RETURNED FOR EVALUATION. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) INTO THE CAPSULAR BAG, THE IOL OPTIC CRACKED, CAUSING CAPSULE DAMAGE. THE IOL WAS REMOVED, A VITRECTOMY WAS PERFORMED, AND A 3-PIECE IOL WAS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED.

Additional Manufacturer Narrative

A REVIEW OF DEVICE HISTORY RECORD (DHR) DID NOT FIND ANY NON-CONFORMITIES OR ANOMALIES RELATED TO THE REPORTED EVENT. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS, AND DIRECTIONS FOR USE ARE 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

INJECTOR WAS RETURNED AND EVALUATED. MICROSCOPIC EXAMINATION FOUND THE LENS MISSING IN THE INJECTOR. THE SHUTTLE AND CARTRIDGE WERE DETACHED FROM THE INJECTOR FOR EVALUATION AND THE LENS WAS NOT FOUND. INVESTIGATION OF THIS EVENT IS STILL IN PROGRESS. WE WILL SEND A FOLLOW UP REPORT ONCE INVESTIGATION IS COMPLETED.