BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 3031078 · Received March 28, 2013

    Report

    Report Number
    3003288808-2013-00128
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 27, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REP REPORTED ON BEHALF OF THE CUSTOMER THAT THE PROGRAMMED FLAP THICKNESS WAS DIFFERENT THAN MEASURED FLAP THICKNESS ON PACHYMETRY. THE THICKNESS SETTING ON THE FEMTOSECOND LASER WAS SET TO 120 MICRONS AND THE MEASURED THICKNESS BY THE EXCIMER WAS 110 MICRONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128606 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC FEMTOSECOND LASER GEX WAVELIGHT GMBH FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 WAVELIGHT EX 500