BEUDAMED
    FDA Adverse Event Other Summary report: N

    REZOOM MULTIFOCAL LENS

    MDR report key: 1220908 · Received November 2, 2008

    Report

    Report Number
    MW5008869
    Event Type
    Other
    Date Received
    November 2, 2008
    Date of Event
    February 18, 2008
    Report Date
    November 2, 2008
    Manufacturer
    AMO
    Product Code
    MFK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ELECTED TO HAVE REZOOM LENS IMPLANTED TO CORRECT CATARACT IN RIGHT -DOMINANT- EYE IN 2008. DISCUSSED KNOWN SIDE EFFECTS -HALOS AND GLARE- WITH SURGEON, WHO INDICATED THAT THESE ARE RATED AND ALMOST ALWAYS GO AWAY WITHIN 3-MONTHS AFTER SURGERY. ALMOST IMMEDIATELY AFTER SURGERY, COMPLAINED TO SURGEON ABOUT HALOS, BLURRED VISION, AND GLARE WHICH WERE ESPECIALLY PROBLEMATIC AT NIGHT OR IN LOW LIGHT. SURGEON SUGGESTED WAITING FOR 3-6 MONTHS, SINCE IT ALMOST ALWAYS GOES AWAY. AT VISIT WITH SURGEON AT 6 MONTH TIME POINT, SURGEON EXPLAINED THAT DOWN SIDE TO REPLACING LENS AT THIS LATE DATE COULD CREATE FAR WORSE PROBLEMS THAT CURRENTLY EXPERIENCING AND THAT HE RECOMMENDED NOT REPLACING. DATES OF USE: 2008 TO CURRENT. DIAGNOSIS OR REASON FOR USE: CATARACT. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REZOOM MULTIFOCAL LENS NONE MFK AMO

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other