MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Description of Event or Problem

A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE PRIMING THE SURGEON FOUND THAT IT WAS DIFFICULT TO MOVE THE LENS INSIDE THE CARTRIDGE, FOR WHICH THE SURGEON DECIDED NOT TO IMPLANT IT, THE LENS WAS REMOVED AND SURGEON FOUND PARTIAL FRACTURE IN ITS OPTICS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE ISSUE AROSE WHEN, DURING LENS MOUNTING WITH CARTRIDGE AND THE COMPANY LENS HOLDER, THE LENS WAS DIFFICULT TO MOVE WITHIN THE CARTRIDGE. THEREFORE, THE DECISION WAS MADE NOT TO IMPLANT IT. THE LENS WAS REMOVED, AND A PARTIAL FRACTURE OF THE OPTIC WAS FOUND. THE SCHEDULED PROCEDURE WAS CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE LENS WAS REMOVED FROM THE CARTRIDGE. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS NOT HOSPITALIZED. ROUTINE POSTOPERATIVE TREATMENT FOR CATARACT SURGERY WAS PRESCRIBED.

Additional Manufacturer Narrative

A PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. 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.