BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EYELITE LASER

    MDR report key: 1031994 · Received April 21, 2008

    Report

    Report Number
    2028159-2008-00141
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 22, 2008
    Report Date
    March 22, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    GEX
    PMA / PMN Number
    K914334
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE REPORTED PROBLEM. THE SYSTEM WAS CALIBRATED TO FIX THE ISSUE. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SURGEON WAS PERFORMING INDIRECT LASER (LIO) WHEN AN ERROR MESSAGE APPEARED ON THE SCREEN. THEY SHUT DOWN THE SYSTEM AND RE-BOOTED, BUT THE ERROR MESSAGE PERSISTED. THE SURGEON ABORTED THE LIO AND FINISHED WITH CRYOPEXY. ADDITIONAL INFO REC'D STATED THE MODE WAS CONFIRMED BEFORE FIRING THE LASER. THE FILTER WAS IN PLACE. THE EVENT OCCURRED WITHIN 1 TO 3 'STEPS' ON THE PEDAL.

    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