BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 2214024 · Received August 3, 2011

    Report

    Report Number
    3006723646-2011-00166
    Event Type
    Other
    Date Received
    August 3, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 3, 2011
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED AND THEN EXPLANTED THE LENSE BECAUSE THE ANATOMY OF THE PT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention