BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 2844581 · Received November 12, 2012

    Report

    Report Number
    3003288808-2012-00478
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 10, 2012
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A LASIK PROCEDURE, THE PT'S EYE MOVED AND SUCTION WAS LOST. THE FLAP WAS COMPLETED, HOWEVER, THE FLAP CUT WAS PARTIALLY INCOMPLETE. THE SURGEON USED A DIAMOND BLADE TO COMPLETE THE CUT, AND THE RELATIVE TREATMENT WAS DELIVERED. NO PT HARM 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 GEX WAVELIGHT GMBH FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR