MONARCH IOL DELIVERY SYSTEM, CARTRIDGE

Description of Event or Problem

A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED TEARS. THE LENS WAS CAREFULLY INSPECTED BEFORE LOADING AND NO TEARS WAS OBSERVED. AFTER THE LENS UNFOLDED IN THE PATIENT EYE A SIGNIFICANT TEAR WAS SEEN. THE TEARS MUST HAVE OCCURRED IN CONNECTION WITH THE LOADING OF THE LENSES. DURING LOADING, THE UTMOST CARE WAS TAKEN, THE OPTIC WAS NOT TOUCHED, AND ALL CONTACT WAS MADE ONLY WITH THE HAPTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WAS LEFT IN PATIENT EYE.

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). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.