STIFF 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPER (DDMS¿)

Additional Manufacturer Narrative

THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE PRODUCT WAS NOT AVAILABLE FOR RETURN; THEREFORE, AND EVALUATION CANNOT BE PERFORMED. IT IS UNKNOWN IF THIS PRODUCT WAS USED WITH A VALVED CANNULA. IF SO, DIRECTIONS WARN, ONLY RETRACTABLE DDMS PRODUCTS ARE COMPATIBLE WITH VALVED CANNULA SYSTEMS. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.

Description of Event or Problem

THE USER FACILITY REPORTED THERE WAS SOME DUST IN THE EYE OF THE RETINA PEEL CASES. THE SURGICAL TEAM WAS NOT SURE IF IT COULD HAVE COME FROM THE INSTRUMENT. THE SURGEON WAS ABLE TO ASPIRATE THE DUST OUT AND FOLLOW UP SHOWED NO ISSUES.