BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS MULTIFOCAL

    MDR report key: 1810533 · Received August 21, 2010

    Report

    Report Number
    9614546-2010-00043
    Event Type
    Injury
    Date Received
    August 21, 2010
    Date of Event
    May 19, 2010
    Report Date
    July 22, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) REMAINS IMPLANTED. DURING FOLLOW-UP WITH THE REPORTER, SHE STATED HER VISION APPEARS TO BE IMPROVING. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS. THE LENS MET MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PATIENT REPORTED SHE IS EXPERIENCING HALOS AND GLARE AT NIGHT AFTER IMPLANTATION OF A MULTIFOCAL INTRAOCULAR LENS (IOL). THE IOL REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MULTIFOCAL MULTIFOCAL IOL MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 Other