BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZOOM

    MDR report key: 1890057 · Received November 3, 2010

    Report

    Report Number
    2648035-2010-00209
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    March 7, 2007
    Report Date
    October 7, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P960028/SO11
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) ASSOCIATED WITH THIS REPORT REMAINS IMPLANTED. IN FOLLOW-UP WITH THE PATIENT'S SURGEON HE STATED THE PATIENT IS UNABLE TO ADJUST TO THE MULTIFOCALITY OF THE IOL. HALOS AND/OR GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF ALL MULTIFOCAL LENS IMPLANTS. WHILE WE WERE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THIS EVENT OUR INVESTIGATION REASONABLY SUGGESTS IT IS NOT MANUFACTURING RELATED. IOL REMAINS IMPLANTED.

    Description of Event or Problem · 1

    LETTER RECEIVED FROM THE PATIENT RELATING THAT HE IS EXPERIENCING BLURRED VISION AND GLARE SINCE IMPLANTATION OF A MULTIFOCAL INTRAOCULAR LENS 3 YEARS AGO. HE RPORTED THAT HE REQUIRES RX MEDICATION DAILY TO RELIEVE THE SYMPTOMS. LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REZOOM MULTIFOCAL INTRAOCULAR LENS MFK ABBOTT MEDICAL OPTICS NXG1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other