BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1053282 · Received May 28, 2008

    Report

    Report Number
    2031924-2008-00191
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 29, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS THAT THE CRYSTALENS TRAILING HAPTIC TORE WHEN DELIVERING THE LENS USING THE AMO SILVER SERIES LENS INJECTOR SYSTEM. THE DETACHED HAPTIC REMAINED IN THE CARTRIDGE. INTERVENTION WAS PERFORMED INTRAOPERATIVELY TO ENLARGE THE ORIGINAL INCISION AND REMOVE THE DAMAGED LENS. A SECOND CRYSTALENS WAS IMPLANTED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 009639

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AMO SILVER SERIES LENS INJECTOR SYSTEM (AMO)