BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REZOOM

    MDR report key: 1020578 · Received March 28, 2008

    Report

    Report Number
    2648035-2008-00012
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    December 31, 2007
    Report Date
    March 11, 2008
    Manufacturer
    ADVANCED MEDICAL OPTICS
    Product Code
    HQL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LENS WAS NOT RECEIVED FOR ANALYSIS. PRODUCT HISTORY RECORDS INDICATE LENS MET ALL CRITERIA PRIOR TO RELEASE. THERE IS CURRENTLY NO EVIDENCE TO SUGGEST THIS ADVERSE EVENT IS MANUFACTURING RELATED.

    Description of Event or Problem · 1

    THE LENS WAS REMOVED AND REPLACED DUE TO THE PATIENT'S VISUAL COMPLAINTS.

    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