BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 3925436 · Received June 18, 2014

    Report

    Report Number
    3003288808-2014-01007
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    March 25, 2014
    Report Date
    May 21, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT HAS BEEN PERFORMED. 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

    A DOCTOR REPORTED SEVERAL PTS EXPERIENCED FLAP FOLDS ONE DAY AFTER SURGERY. THE PTS WERE TAKEN BACK TO THE SURGERY ROOM TO STRETCH THE FLAP. ADDITIONAL INFO WAS RECEIVED FROM THE SURGEON CONFIRMING THE EVENT OCCURRED IN TWO PTS. THIS REPORT IS FOR THE LEFT EYE OF THE SECOND PT WHO UNDERWENT BILATERAL SURGERY AND EXPERIENCED FLAP FOLDS IN BOTH EYES. THE FLAPS WERE REPOSITIONED ON (B)(6) 2014. THE PT WAS VISITED ON (B)(6) 2014 WITH NO REMARKS. THIS IS ONE OF THREE MEDICAL DEVICE REPORTS BEING FILED FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356751 WAVELIGHT FS200 FEMTOSECOND LASER OPHTHALMIC FEMTOSECOND LASER LZS WAVELIGHT GMBH FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention