BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1130907 · Received August 21, 2008

    Report

    Report Number
    2031924-2008-00269
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS.

    Description of Event or Problem · 1

    THE RPTR STATES THAT INJURIES WERE SUSTAINED WHEN THE CRYSTALENS CAME APART DURING THE IMPLANT PROCEDURE. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT50SE 008979

    Patients

    Seq Age Sex Outcome Treatment
    1