BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 2696794 · Received August 10, 2012

    Report

    Report Number
    3003288808-2012-00321
    Event Type
    Injury
    Date Received
    August 10, 2012
    Date of Event
    July 12, 2012
    Report Date
    July 12, 2012
    Manufacturer
    WAVELIGHT AG
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    SURGEON REPORTED THAT A HIGHLY UNCOOPERATIVE PT HAD A LASIK FLAP PROCEDURE, BILATERALLY. AFTER CREATION OF THE CUT THE SURGEON STOPPED THE PROCEDURE BEFORE TREATMENT WITH EXCIMER LASER AS PT NO LONGER COOPERATED. A COMPANY REPRESENTATIVE ONSITE OBSERVED THAT THE FLAP SIDECUT WAS NOT VISIBLE, AND AFTER REVIEW NOTED THAT THE ENERGY SETTING USED WAS FOR SERVICE, AS LASER HAD BEEN SERVICED RECENTLY, AND NOT SURGEON¿S DEFAULT SETTING. USER HAD NOT REVIEWED SETTINGS PRIOR TO PROCEDURE. A PHOTOREFRACTIVE KERATECTOMY (PRK) IS PLANNED FOR THE PT. ACCORDING TO SURGEON LASIK WAS CONSIDERED TO BE NO LONGER APPROPRIATE DUE TO LACK OF PT COOPERATION. ADD¿L COMMENTS FROM THE SURGEON INDICATED THAT PT WAS VERY RESTLESS, SEVERAL EYE SUCTION ATTEMPTS WERE MADE, PROCEDURE CANCELED WITH 15 MIN BREAK, ¿STRONG SECRETION¿, AND PATIENT WAS VERY TENSE. 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 AG FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention