BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 3190768 · Received June 20, 2013

    Report

    Report Number
    3006723646-2013-00299
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 20, 2013
    Manufacturer
    HOYA SURGICAL OPTICS INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HAPTIC WAS BENT OVER INCORRECTLY AND HAS TO BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281389 ISERT ASPHERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS INC. 230

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention