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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.

Description of Event or Problem

A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, 2 COMPANY LENSES WERE NOTED TO HAVE LARGE SCRATCHES ON THE INFERIOR ASPECT OF THE LENS AFTER DEPLOYMENT INTO THE BAG (1ST WAS ~5 MM ACROSS) AND THE SECOND WAS A STACCATO DEFECT, ALSO INFERIOR, WITH A THROUGH AND THROUGH CRACK AT THE OPTIC EDGE. THE FIRST LENS WAS LOADED BY ANOTHER PERSON, AND THE SECOND WAS LOADED BY THE INITIAL REPORTER. BOTH USED A DIFFERENT INJECTOR AND DIFFERENT CARTRIDGE FOR THE TWO DIFFERENT LENSES, AND THE REPORTER PERSONALLY INSPECTED THE SECOND LENS BEFORE LOADING IT TO BE SURE IT WAS A PRISTINE LENS (WHICH IT WAS PRIOR TO LOADING). THE ONLY THING THEY COULD THINK OF AS THE CAUSE OF A SCRATCH IN EXACTLY THE SAME PART OF THE OPTIC WAS PERHAPS THE CARTRIDGE ITSELF AS THERE WAS A THIN PIECE OF PLASTIC (PAPER THIN) AT THE EDGE OF THE CARTRIDGE THAT THE REPORTER NOTICED WHEN INSPECTING IT AFTER THIS HAD HAPPENED. THE OTHER POSSIBILITY WOULD BE THE PLUNGER, BUT THE SCRATCH ON THE FIRST AND SECOND LENS WAS IN EXACTLY THE SAME PLACE. THE SURGERY WAS COMPLETED BY IMPLANTING ANOTHER COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THAT THE PATIENT EXPERIENCED CORNEAL EDEMA, IRIS TRAUMA DUE TO INTRAOPERATIVE FLOPPY SYNDROME AND IRIS PROLAPSE FROM MAIN CORNEAL INCISION DURING LONGER THAN EXPECTED INTRAOPERATIVE MANIPULATION DUE TO AFOREMENTIONED LENS ISSUES. THE PATIENT ISSUES RESOLVED 80 PERCENT WITH REASONABLE PROGNOSIS, BUT THE PATIENT HAD TWO DIFFERENT LENSES PLACED AND REMOVED WHICH CAUSED HIGHER POSTOPERATIVE CORNEAL EDEMA THAN EXPECTED.