BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISYMM ASPHERIC INTRAOCULAR LENS

    MDR report key: 1481039 · Received July 17, 2009

    Report

    Report Number
    3006723646-2009-00005
    Event Type
    Malfunction
    Date Received
    July 17, 2009
    Date of Event
    August 13, 2009
    Report Date
    September 17, 2009
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HOYA SURGICAL OPTICS, INC. (HSO) HAS CONTACTED THE USER FACILITY AND CONFIRMED THAT: THE HAPTIC DETACHED BEFORE THE SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO WOUND ENLARGEMENT OR ADDITIONAL SURGICAL INTERVENTION. ALSO, THERE HAS BEEN NO INCREASE IN THE FREQUENCY OF THE DETACHED HAPTIC. THEREFORE, WE ARE FILING A MALFUNCTION MDR.

    Description of Event or Problem · 1

    DETACHED HAPTIC FROM LENS LOADING ERROR. THE LENS WAS INSERTED IN THE EYE, THEN EXPLANTED.

    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 70 YR Required Intervention