MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CARTRIDGE WAS CRACKING WHEN THE LENS WAS BEING INSERTED. THERE WAS NO PATIENT HARM. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 4 OF 4. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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).