MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

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).

Description of Event or Problem

A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE ARM ON THE LENS BROKE DURING IMPLANTATION AND IN THE SURGEON'S OPINION, THE CARTRIDGE LOCKED NARROW CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.