BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZOOM

    MDR report key: 1063386 · Received June 19, 2008

    Report

    Report Number
    2648035-2008-00030
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    MFK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT WAS CUT IN TWO PIECES ACROSS THE OPTIC WHEN RECEIVED PRECLUDING ANALYSIS. PRODUCT HISTORY RECORDS INDICATE THE LENS MET ALL CRITERIA PRIOR TO RELEASE. THERE IS NO EVIDENCE TO SUGGEST THIS ADVERSE EVENT IS MANUFACTURING RELATED. THERE WERE NO ADDITIONAL COMPLAINTS RECEIVED FOR ADDITIONAL LENSES MANUFACTURED IN THIS WORKORDER.

    Description of Event or Problem · 1

    THE INTRAOCULAR LENS WAS REMOVED AND REPLACED AT AN UNIDENTIFIED FACILITY DUE TO THE PATIENT'S DISSATISFACTION WITH THEIR READING AND DISTANCE VISION. SECONDARY SURGERY WAS UNCOMPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REZOOM MULTIFOCAL INTRAOCULAR LENS MFK ADVANCED MEDICAL OPTICS MXG1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention