MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Description of Event or Problem

A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS ISSUE WITH THE CARTRIDGE. WHEN THEY INSERT THE CARTRIDGE AND TRIED TO IMPLANT, THE PLUNGER DOES NOT INSERT THE LENS IT WAS GOING UNDER THE LENS. ALSO, DOCTOR HAD A PROBLEM FITTING THE CARTRIDGE INTO THE INCISION AND HAD TO MAKE IT WIDER TO GET THE LENS IN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.

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.