MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE CARTRIDGE HAD SPLIT OPEN. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED ON 05-MAR-2026, THE EVENT OCCURRED BEFORE SURGERY THERE WAS NO PATIENT CONTACT. THE LENS WAS SCRATCHED DUE TO CARTRIDGE. THE SURGERY WAS COMPLETED USING A NEW CARTRIDGE AND A NEW LENS ON THE SAME DAY. THE SURGERY WAS PERFORMED ON THE PATIENTS LEFT EYE AND THE PATIENT ISSUE WAS RESOLVED.

Additional Manufacturer Narrative

THE 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.