MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE CARTRIDGE BEGAN TO CRACK WHILE THE LENS WAS BEING INSERTED. NO PATIENT HARM OCCURRED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT CARTRIDGE CRACKED, AND THE TIP WAS SPLIT AT TOP WHEN IOL WAS ADVANCED INTO BAG, BUT LENS HAD NO DEFICIENCIES. THE LENS REMAINS IMPLANTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 4.

Additional Manufacturer Narrative

THE 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.