BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZOOM

    MDR report key: 1050312 · Received May 22, 2008

    Report

    Report Number
    2648035-2008-00029
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 30, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    MFK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LENS WAS RECEIVED CUT IN 2 PIECES ACROSS THE OPTIC MAKING ANALYSIS OF THE DEVICE IMPOSSIBLE. HALOS AND GLARE ARE A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF A MULTIFOCAL IMPLANT. THERE HAVE BEEN NO SIMILAR REPORTS RECEIVED FOR PRODUCT IN THIS BATCH RECORD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT THAT SHE HAD HER MULTIFOCAL INTRAOCULAR LENS REMOVED AND REPLACED WITH A MONOFOCAL IOL, DUE TO THE VISUAL ISSUES SHE WAS EXPERIENCING. SHE EXPERIENCED HALOS AND GLARE AND DIFFICULTY WITH HER NIGHT VISION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention