BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 3954720 · Received July 18, 2014

    Report

    Report Number
    3003288808-2014-01136
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING LASIK SURGERY, WHILE CREATING THE FLAP FOR THE RIGHT EYE, THE SURGEON CUT A TISSUE OVERGROWTH WHICH RESULTED IN A HEMORRHAGE. THE OVERGROWTH WAS PREEXISTENT AND WAS LOCATED NEAR THE IRIS. THE SURGEON CUT AS INFERIORLY AS POSSIBLE IN ORDER TO AVOID CUTTING THE OVERGROWTH, YET IT WAS STILL BUT BY THE LASER. THE BLEEDING WAS CONTROLLED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422139 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC FEMTOSECOND LASER GEX WAVELIGHT GMBH FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention