BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EYELITE LASER

    MDR report key: 1033483 · Received April 24, 2008

    Report

    Report Number
    2028159-2008-00145
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    GEX
    PMA / PMN Number
    K914334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CO SERVICE REP EXAMINED THE SYS AND FOUND THE LASER INDIRECT OPHTHALMOSCOPE (LIO) FIBER WAS BROKEN. THE LIO FIBER WAS REPLACED. THE SYS WAS TESTED AND PASSED ALL PRODUCT SPECS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO AIMING BEAM WAS AVAILABLE ON THE SYSTEM. A CRYOPEXY WAS PERFORMED TO COMPLETE THE CASE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EYELITE LASER LASER INSTRUMENT, SURGICAL, POWERED GEX ALCON - IRVINE TECHNOLOGY CENTER EYELITE LASER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI