BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZOOM

    MDR report key: 1233859 · Received November 13, 2008

    Report

    Report Number
    2648035-2008-00055
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 21, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    MFK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LENS WAS RECEIVED IN A CONDITION THAT MADE ANALYSIS IMPOSSIBLE. THERE IS NO EVIDENCE TO SUGGEST THIS ADVERSE EVENT IS MANUFACTURING RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS WAS REMOVED AND REPLACED DUE TO PRE OPERATIVE CALCULATION ERRORS. A NEW LENS WAS IMPLANTED WITHOUT COMPLICATION OR PATIENT INJURY.

    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