BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAOCULAR LENS

    MDR report key: 11874947 · Received May 24, 2021

    Report

    Report Number
    MW5101524
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    May 18, 2021
    Report Date
    May 21, 2021
    Manufacturer
    ALCON RESEARCH, LLC
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE WERE USING A SPECIAL ORDER LENS MA60MA 3.0 ALCON LENS. THE LENS WAS LOADED CORRECTLY AND WAS INJECTED EASILY AND UPON INJECTION WE NOTICED THE LEADING HAPTIC WAS BROKEN IN THE MIDDLE. I PERSONALLY HAVE NEVER SEEN ONE BROKEN IN THIS SPOT ITS NOT A COMMON BREAK. WE REMOVED THE LENS BY CUTTING IT IN HALF THEN USED THE BACK UP LENS WHICH WAS NOT DAMAGED. NO SPECIAL NEEDS FOR THE PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765392 INTRAOCULAR LENS INTRAOCULAR LENS HQL ALCON RESEARCH, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR