BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2172759 · Received July 22, 2011

    Report

    Report Number
    9614546-2011-00055
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE OPTIC TOOK PLACE AND NO OPTICAL DEVIATIONS COULD BE FOUND. MANUFACTURING RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL INTRAOCULAR LENSES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY SUGGESTING THIS EVENT WAS NOT CAUSED BY A DEFICIENT PRODUCT. NO PATIENT COMPLICATIONS. ALL INFORMATION CURRENTLY AVAILABLE IS PROVIDED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MULTIFOCAL INTRAOCULAR LENS WAS EXPLANTED DUE TO THE PATIENT'S REPORT OF HALOS AND GLARE. NO PATIENT COMPLICATIONS. AN ALTERNATE LENS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL LENS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention