BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 3810860 · Received March 20, 2014

    Report

    Report Number
    3006723646-2014-00339
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 20, 2014
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P08004
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAPTIC BROKE IN HALF RIGHT AFTER LENS WAS IMPLANTED. LENS HAD TO BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167706 ISERT ASPHERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS INC. FC-60AD

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention