BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 3853395 · Received April 4, 2014

    Report

    Report Number
    3006723646-2014-00342
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 4, 2014
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAPTIC BROKE DURING INSERTION INTO THE EYE. LENS HAD TO EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204928 ISERT ASPHERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS INC. 230

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention