BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 2191352 · Received July 27, 2011

    Report

    Report Number
    3003288808-2011-00233
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 ADD'L INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTS THE NEED TO INCREASE THE ENERGY IN ORDER TO COMPLETE THE SIDE CUT. NO INJURY WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC FEMTOSECOND LASER LZS WAVELIGHT GMBH FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1