BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1061203 · Received June 16, 2008

    Report

    Report Number
    2031924-2008-00217
    Event Type
    Injury
    Date Received
    June 16, 2008
    Report Date
    May 28, 2008
    Manufacturer
    EYEONICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    AN FDA DISTRICT OFFICE CONTACTED EYEONICS TO INFORM US OF A PATIENT WHO UNDERWENT CATARACT SURGERY WITH BILATERAL IMPLANTATION OF THE CRYSTALENS. THE SURGERIES WERE PERFORMED TWO DAYS IN 2007. POSTOPERATIVELY, SECONDARY SURGICAL INTERVENTION WAS PERFORMED AND THE PATIENT'S VISION IS WORSE COMPARED TO PREOPERATIVE VISION. NO ADDITIONAL DETAILS WERE PROVIDED AND NO DEVICE SPECIFIC INFORMATION (MODEL, SERIAL NUMBER, ETC.) WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention