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 HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STUCK IN THE CARTRIDGE, & WHEN INJECTED INTO THE EYE IT WAS DAMAGED. SO, THE LENS HAD TO BE CUT OUT. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED BY THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM AND THE PATIENT CURRENT CONDITION IS GOOD.