BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REZOOM

    MDR report key: 1081380 · Received July 7, 2008

    Report

    Report Number
    1081380
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    November 7, 2007
    Report Date
    December 7, 2007
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN IMPLANTED AN OCULAR LENS - ONCE IT WAS INSERTED HE NOTICED A SCRATCH ACROSS THE LENS. THE LENS WAS CUT BY PHYSICIAN AND TAKEN OUT IN PIECES WITHOUT ANY PROBLEMS. A SECOND LENS WAS INSERTED AND PROCEDURE COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *