ENVISTA SIMPLIFEYE INSERTER

Additional Manufacturer Narrative

THE HOSPITAL CONFIRMED THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF DEVICE HISTORY RECORD (DHR) DID NOT IDENTIFY ANY ANOMALIES OR NON-CONFORMITIES THAT COULD BE 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 IS "DESIGN".

Description of Event or Problem

IT WAS REPORTED THAT DURING IMPLANTATION AN ADVERSE EVENT OCCURRED DURING SURGERY WHERE THE TIP OF AN ENVISTA INJECTOR SNAPPED INSIDE THE PATIENT¿S EYE. THE PATIENT REQUIRED AN ENLARGED INCISION (ABOUT 3.5 MM) AND REMOVAL OF THE FOREIGN BODY, FOLLOWED BY TWO STITCHES. THE ORIGINAL LENS REMAINED IN PLACE PRIOR TO THE INJECTOR TIP SNAPPING OFF, SO THAT LENS STAYED IN THE EYE. THE SURGEON'S OPINION ATTRIBUTES THE ISSUE TO THE ENVISTA INJECTOR. THE PATIENT HAS RECOVERED.