BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZOOM

    MDR report key: 1033298 · Received April 22, 2008

    Report

    Report Number
    2648035-2008-00017
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LENS WAS RECEIVED AND INSPECTED UNDER 10X MAGNIFICATION, NO DEFECTS FOUND. PRODUCT HISTORY RECORDS INDICATE LENS MET ALL CRITERIA PRIOR TO RELEASE. THERE IS NO EVIDENCE TO SUGGEST THIS ADVERSE EVENT IF MFG RELATED. PT WAS UNABLE TO ADAPT TO THE MULTIFOCALITY OF THE LENS. VISUAL EFFECTS ARE A KNOWN POSSIBLE SIDE EFFECT OF MULTIFOCAL LENS IMPLANTATION.

    Description of Event or Problem · 1

    THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS DUE TO THE INABILITY OF THE PT TO ADAPT TO THE MULTIFOCALITY OF THE LENS. PT WAS EXPERIENCING HALOS AND GLARE, A KNOWN AND LABELED POSSIBLE SIDE EFFECT OF MULTIFOCAL LENSES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention