MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POOR MIDRANGE AND NEAR VISION. HENCE, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WAS A DAMAGED LENS HAPTIC, WHICH DID NOT REMAIN CENTERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED, STATING THAT THE SURGEON WHO PERFORMED THE SURGERY NOTED LENS DECENTRATION AND A COMPLAINT OF POOR NEAR VISION ON THE FIRST POST-OPERATIVE DAY. DAMAGE TO THE LENS HAPTIC WAS NOT NOTICED UNTIL INTRAOPERATIVELY DURING THE IOL EXCHANGE, AS THE LENS OPTIC-HAPTIC JUNCTION WAS NOT VISIBLE ON DILATED EXAMINATION FOLLOWING THE FIRST SURGERY DUE TO THE DECENTRATION. IN THE SURGEON'S OPINION, THE LENS IMPLANT LIKELY BECAME DAMAGED DURING INSERTION USING A COMPANY INJECTOR AND CARTRIDGE. THERE WAS NO FURTHER IMPACT ON THE PATIENT, AND THE SURGEON'S PROGNOSIS WAS EXCELLENT.

Additional Manufacturer Narrative

A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE REPORTING FACILITY DID NOT PROVIDE A VALID LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. 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.