BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 2181323 · Received July 8, 2011

    Report

    Report Number
    3006723646-2011-00155
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 8, 2011
    Manufacturer
    HOYA SURGICAL OPTICS, LLC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LENS WAS EXPLANTED BECAUSE THE HAPTIC WAS DEFORMED WHEN IT WAS PUSHED THROUGH THE CARTRIDGE. HAPTIC BROKE DURING LENS EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISYMM ASPHERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, LLC. FC-60AD

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention