MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CARTRIDGE WAS CRACKING WHEN THE LENS WAS BEING INSERTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT CARTRIDGE CRACKED, AND THE TIP WAS SPLIT AT TOP WHEN IOL WAS ADVANCED INTO BAG, BUT LENS HAD NO DEFICIENCIES. THE LENS REMAINS IMPLANTED.