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).

Description of Event or Problem

A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS SCRATCHED DURING IMPLANTATION. THE SCRATCHES WERE ON THE EDGE OF THE LENS, SURGEON ROTATED THE LENS SO THAT THE DAMAGED AREA WOULD BE POSITIONED UPWARDS UNDER THE EYELID TO MINIMIZE DISCOMFORT FOR THE PATIENT AND THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.