BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON LABORATORIES, INC.

    MDR report key: 2514245 · Received March 26, 2012

    Report

    Report Number
    MW5024829
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    March 7, 2012
    Report Date
    March 23, 2012
    Manufacturer
    ALCON
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO MANEUVER IOL INTO SULCUS (FORCEP/TIER) HOLDING HAPTIC, HAPTIC SNAPPED/FELL OFF THE OPTIC THE OPTIC/OTHER HAPTIC THEN FELL INTO VITREOUS. I DID NOT THINK ANYTHING OF IT UNTIL THE VITRETINAL SURGEON SAID THE SAME EVENT OCCURRED IN HER REMOVING THE IOL BY THE OTHER HAPTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCON LABORATORIES, INC. ACRYSOF NATURAL IOL HQL ALCON MN60AC

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR