BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPHTHALAS 532 EYELITE LASER SYSTEM

    MDR report key: 1791623 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01422
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Report Date
    July 7, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    GEX
    PMA / PMN Number
    K914334
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO INFO." (NO INFO). PRODUCT PROBLEM(S): "UNIT FIRING INTERMITTENTLY." (DEVICE STOPS INTERMITTENTLY); "SYSTEM MESSAGE DISPLAYED." (DEVICE DISPLAYS ERROR MESSAGE); "SYSTEM SHUT DOWN." (OPERATING SYSTEM BECOMES NON-FUNCTIONAL). A CUSTOMER REPORTED THE LASER WAS INTERMITTENTLY NOT FIRING. THE SYSTEM THEN DISPLAYED A POWER OUT OF RANGE SYSTEM MESSAGE FORCING A SHUT DOWN. ADDITIONAL INFO HAS BEEN REQUESTED.

    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 CTR 8065500001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1