ENVISTA SIMPLIFEYE INSERTER

Description of Event or Problem

IT WAS REPORTED THAT AFTER INSERTION OF AN INTRAOCULAR LENS (IOL) INTO THE PATIENT'S LEFT EYE, THE SURGEON NOTICED A HAPTIC WAS BROKEN AND REMAINED IN THE INJECTOR. THE INCISION WAS ENLARGED TO ALLOW FOR REMOVAL OF THE IOL AND A SUCCESSFUL INTRAOPERATIVE IOL EXCHANGE WAS PERFORMED USING A BACKUP IOL OF THE SAME MODEL AND DIOPTER. ONE CORNEAL SUTURE WAS USED TO CLOSE THE INCISION AND WAS REMOVED 8 DAYS POST-OP. PATIENT OUTCOME IS REPORTEDLY FINE.

Additional Manufacturer Narrative

THE DEVICE WAS DISCARDED AND THEREFORE NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DID NOT IDENTIFY ANY ANOMALIES OR NONCONFORMITIES THAT COULD BE RELATED TO THIS EVENT. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. BASED ON THE AVAILABLE INFORMATION, USER RELATED FACTORS (SUCH AS LOADING OR HANDLING TECHNIQUES) AND/OR PROCEDURAL FACTORS (SUCH AS LENS AND INSERTER INTERACTION) MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.