BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZOOM

    MDR report key: 1813509 · Received August 24, 2010

    Report

    Report Number
    2648035-2010-00154
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 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

    (B)(4). THE INTRAOCULAR LENS (IOL) ASSOCIATED WITH THIS REPORT REMAINS IMPLANTED. IN FOLLOW-UP WITH THE PATIENT'S SURGEON HE STATED THE PATIENT'S VISUAL ACUITY WAS 20/25 WITH SOME RESIDUAL ASTIGMATISM AT HIS LAST VISIT A YEAR AGO. IN HIS OPINION, THE PATIENT IS UNABLE TO ADJUST TO THE MULTIFOCALITY OF THE IOL AND THE LENS IS WELL CENTERED AND NOT DEFECTIVE. 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 HALOS AND GLARE AT NIGHT AFTER IMPLANTATION OF A MULTIFOCAL INTRAOCULAR LENS 3 YEARS AGO. 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 74 YR Other