BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 1791824 · Received August 4, 2010

    Report

    Report Number
    3006723646-2010-00079
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 13, 2010
    Report Date
    August 4, 2010
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AS THE DOCTOR WAS INSERTING THE LENS INTO THE EYE, HE NOTICED, THE LENS HAD BEEN LOADED INCORRECTLY. LENS DID NOT EJECT PROPERLY BECAUSE OF MISLOADING AND HAD TO BE EXPLANTED. PT WAS NOT INJURED. ANOTHER HOYA LENS WAS USED WITH NO COMPLICATIONS.

    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 85 YR Required Intervention