BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 2043544 · Received February 25, 2011

    Report

    Report Number
    3006723646-2011-00051
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 25, 2011
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LENS WAS EXPLANTED BECAUSE, THE DOCTOR TORE THE CAPSULAR BAG AND HAD TO IMPLANT AN ANTERIOR CHAMBER LENS. NO ALLEGED HOYA LENS DEFECT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention