MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Description of Event or Problem

A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED IOL WAS SCRATCHED DURING IMPLANTATION, THEY WERE IMPLANTED IN THE PATIENTS. IT WAS STATED THAT THE IOLS WERE ROTATE SO THAT THE DAMAGED AREA WOULD BE POSITIONED UPWARDS UNDER THE EYELID, TO MINIMIZE DISCOMFORT FOR THE PATIENTS. ADDITIONAL INFORMATION WAS REQUESTED.

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).