BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALENS

    MDR report key: 1082540 · Received July 23, 2008

    Report

    Report Number
    2031924-2008-00250
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTS THAT THE LENS DAMAGE WAS NOTICED WHEN OPENING THE PACKAGING. NO LENS WILL BE RETURNED. UNABLE TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE CRYSTALENS HAPTIC WAS TORN. THE LENS DAMAGE WAS OBSERVED WHEN THE LENS CASE WAS OPENED; NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 009340

    Patients

    Seq Age Sex Outcome Treatment
    1