MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

A PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE REPORTED PRODUCT LOT NUMBER WAS NOT PROVIDED. LOT SPECIFIC REVIEWS FOR SIMILAR COMPLAINTS OR NON-CONFORMANCES COULD NOT BE CONDUCTED. HOWEVER, BEFORE PRODUCTION RELEASE, EACH DEVICE HISTORY RECORD IS REVIEWED TO ENSURE THAT THE PRODUCT MET THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. ROOT CAUSE: ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CARTRIDGE INCLUDED IN OUR PACK WAS FOUND TO BE CRACKED. THE CRACK WAS NOTICED WHILE LOADING THE LENS, AND AS A RESULT, THE LENS BECAME MANGLED WHEN ATTEMPTING TO ADVANCE IT INTO THE PATIENT'S CAPSULAR BAG. ADDITIONAL INFORMATION WAS REQUESTED.