EASY-LOAD LENS DELIVERY SYSTEM

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED AND EVALUATED. EXAMINATION FOUND THE INJECTOR SPLIT AFTER SLIT AREA OF THE CARTRIDGE TIP. A SMALL AMOUNT OF VISCOELASTIC WAS OBSERVED IN THE LOADING AREA OF LENS AND NO VISCOELASTIC WAS OBSERVED IN THE TIP OF THE INJECTOR. 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 CONTRIBUTED TO THE EVENT.

Description of Event or Problem

AN EYE SURGERY CENTER REPORTED THAT DURING INSERTION OF AN INTRAOCULAR LENS (IOL) THE TIP OF THE INJECTOR CRACKED AND THE LENS WENT OUT THE SIDE. THERE WAS NO INJURY TO THE PATIENT AND A BACKUP LENS WAS SUCCESSFULLY IMPLANTED WITH NO NEGATIVE PATIENT IMPACT.