MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D

Additional Manufacturer Narrative

A PRODUCT WAS NOT RETURNED FOR ANALYSIS. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED, AND DOCUMENTATION INDICATED THE PRODUCT MET RELEASE CRITERIA. 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 NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS THAT WERE IMPLANTED CAREFULLY INSPECTED BEFORE LOADING. NO TEARS WERE OBSERVED AT THAT STAGE. HOWEVER, AFTER THE LENS UNFOLDED IN THE PATIENT¿S EYE, A SIGNIFICANT TEAR WAS SEEN. THIS MEANS THAT THE TEARS MUST HAVE OCCURRED IN CONNECTION WITH THE LOADING OF THE LENSES. THEY TRIED USING EXTRA VISCOELASTIC, WHICH FEELS BETTER, BUT THIS HAD NOT PREVENTED NEW TEARS FROM OCCURRING. DURING LOADING, THE UTMOST CARE WAS TAKEN, THE OPTIC WAS NOT TOUCHED AT ALL, AND ALL CONTACT WAS MADE ONLY WITH THE ¿HAPTICS/LEGS¿. DESPITE THIS, THE LENS SHOWED TEARS ACROSS THE OPTIC ONCE THEY UNFOLDED INSIDE THE EYES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WAS LEFT IN THE PATIENT EYE.