MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

A PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW AND A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER WAS CONDUCTED. THE DEVIATION REVIEW DID NOT REVEAL ANY POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED COMPLAINT AND ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. 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.

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, WHEN THE IOL WAS BEING INSERTED, OPTICAL DAMAGE OCCURRED AND THE LENS WAS SCRATCHED WITHIN THE DELIVERY SYSTEM WITH PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.