MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Description of Event or Problem

A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED BY CARTRIDGE WHEN ADVANCED DURING LOADING. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT THE SURGEON REPORTED THAT LENS FELT TOO TIGHT. UPON SCRUTINY OF THE LENS UNDER MICROSCOPE THE SIDE OF THE LENS HAD BECOME CUT WHEN FORWARDING INTO CARTRIDGE. THE HAPTICS WERE CORRECTLY ORIENTED, SO IT WAS SUSPECTED THAT THE CARTRIDGE DAMAGED THE LENS WITH ADVANCEMENT.

Additional Manufacturer Narrative

A 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).