BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 770144 · Received October 17, 2006

    Report

    Report Number
    2031924-2006-00029
    Event Type
    Injury
    Date Received
    October 17, 2006
    Date of Event
    August 28, 2006
    Report Date
    September 21, 2006
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THE IOL REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE UNAVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH DECREASED VISUAL ACUITY ONE MONTH AFTER CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE RIGHT EYE. THE PATIENT WAS DIAGNOSED WITH CYSTOID MACULAR EDEMA AND THE FLUORESCEIN ANGIOGRAPHY REVEALED SLIGHT MACULAR EDEMA EXTENDING FROM THE TOP OF A BRANCH VEIN OCCLUSION (LOCATED INFERIOR TO THE RIGHT MACULA). THE BVO WAS NOTED PREOPERATIVELY. THE PATIENT WAS TREATED WITH TOPICAL STEROID & NSAID GTTS AND INTRAVITREAL INJECTION OF KENALOG. THE PHYSICIAN BELIEVES THE CME IS SECONDARY TO THE BVO AND NOT TO THE CRYSTALENS, HOWEVER THE EVENT IS BEING REPORTED CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS HQL EYEONICS, INC. AT-45SE 003938

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention