ENVISTA SIMPLIFEYE INJECTOR

Description of Event or Problem

THE HEALTHCARE FACILITY REPORTED THAT DURING AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) ONE OF THE HAPTICS TORE OFF. THE LENS WAS REMOVED AND THE BACKUP IOL WAS IMPLANTED. THE PATIENT IS SEVERELY HYPEROPIC AND HAS A VERY NARROW ANTERIOR CHAMBER, MAKING MANIPULATION DIFFICULT FROM THE POINT OF VIEW OF THE CORNEAL ENDOTHELIUM, AND THE REMOVAL OF THE DEFECTIVE IMPLANT PROMOTED AN IRIS HERNIA. THIS REQUIRED ADDITIONAL SEDATION (PROPOFOL) FOR PATIENT PAIN AND INCREASED THE OPERATING TIME BY ABOUT 15 MINUTES (ENLARGEMENT OF THE MAIN INCISION, CUTTING WITH OFFSET SCISSORS, REMOVAL OF THE SEGMENTED IOL, REINJECTION OF THE BACKUP IOL, REINTEGRATION OF THE IRIS, INJECTION OF MIOSTAT (CARBACHOL), AND PLACEMENT OF A SUTURE). THE SURGEON DOESN¿T THINK THERE WILL BE ANY CONSEQUENCES IN TERMS OF VISUAL ACUITY. THE AFTER-EFFECTS SHOULD BE LIMITED TO AN IRIS SCAR, WHICH IS USUALLY ASYMPTOMATIC.

Additional Manufacturer Narrative

THE INJECTOR WAS RETURNED FOR EVALUATION. THE INJECTOR WAS RECEIVED WITH THE SHUTTLE ASSEMBLY CORRECTLY ATTACHED. THE LENS WAS NOT IN THE CARTRIDGE. THE SHUTTLE ASSEMBLY WAS REMOVED/DETACHED FROM THE INJECTOR AND DISSEMBLED FOR INSPECTION. FURTHER INSPECTION REVEALED A LENS FRAGMENT TRAPPED IN THE LENS PATH; THIS WAS CONFIRMED AS A HAPTIC FROM A LENS. 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.