BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALAS 532 EYELITE LASER SYSTEM

    MDR report key: 2102831 · Received April 12, 2011

    Report

    Report Number
    2028159-2011-00538
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    April 12, 2011
    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
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE LASER ENGINE COULD NOT BE CALIBRATED SUCCESSFULLY. THE COMPANY REPRESENTATIVE RECOMMENDED THE LASER ENGINE BE REPLACED. THE CUSTOMER DECLINED TO REPLACE THE LASER ENGINE AT THIS TIME. NO SERVICE TEST PROCEDURE WAS COMPLETED. THE SYSTEM DOES NOT MEET ALL PRODUCT SPECIFICATIONS AND IS INOPERATIVE. THE ROOT CAUSE IS A NONCONFORMING LASER ENGINE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED A SYSTEM MESSAGE WAS RECEIVED IN THE MIDDLE OF A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE NURSE REPORTING THAT THE EVENT OCCURRED AT THE END OF A PROCEDURE. THE SYSTEM WAS SWITCHED OUT AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPHTHALAS 532 EYELITE LASER SYSTEM LASER INSTRUMENT, SURGICAL, POWERED GEX ALCON - IRVINE TECHNOLOGY CENTER 8065500001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1