BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 6534080 · Received May 1, 2017

    Report

    Report Number
    3003288808-2017-01026
    Event Type
    Injury
    Date Received
    May 1, 2017
    Date of Event
    April 6, 2017
    Report Date
    August 1, 2017
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON ACCEPTANCE CRITERIA. 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).

    Additional Manufacturer Narrative · 1

    DATA REVIEW SHOWED THE TREATMENT REPORT DEPICTS A ROUND EDGED SPOT AT THE MARGIN OF THE FLAP AND 11 O¿CLOCK POSITION. THIS SPOT COULD BE CHARACTERIZED AS A VERTICAL GAS BREAKTHROUGH (VGB), CAUSED BY ACCUMULATION OF PHOTO-DISRUPTION BY-PRODUCTS AT THE CUTTING LEVEL AND FINALLY VENTING THROUGH A SYMPTOMATIC BOWMAN- MEMBRANE. LOG FILE REVIEW SHOWS ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS FOR THE RESPECTIVE TREATMENT. HOWEVER, THE INCLINED OFFSET WAS CHANGED FROM +35¿M BY Z-OFFSET -505¿M TO +25¿M BY Z-OFFSET -520¿M DURING PM (PREVENTIVE MAINTENANCE) AND THEN IT WAS CHANGED FROM +25¿M BY Z-OFFSET -520¿M TO +23¿M BY Z-OFFSET -510¿M DURING ANOTHER PM. THE CHANGE OF OFFSET MAY HAVE LEAD TO A THINNER FLAP. THE ROOT CAUSE FOR THIN FLAP COULD NOT BE IDENTIFIED CONCLUSIVELY HOWEVER, A SETTING OF THE CUTTING DEPTH (OFFSET VALUE) WITHIN THE LOWER RANGE OF SPECIFICATION IS THE MOST LIKELY ROOT CAUSE. A POSSIBLE CONTRIBUTING FACTOR COULD BE A FLUID LAYER BETWEEN THE APPLANATION CONE AND THE CORNEA THAT CAN CAUSE A SIGNIFICANTLY REDUCTION OF THE ACHIEVED FLAP THICKNESS IF THE SURGEON USES TOO MUCH BALANCED SALT SOLUTION BEFORE FLAP CUTTING. THE THIN FLAP CAN CAUSE VGB AND DIFFICULTY LIFTING OF THE FLAP. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A VERTICAL GAS BREAKTHROUGH (VGB) OCCURRED IN THE RIGHT EYE DURING A LASIK PROCEDURE. WHILE THE FLAP WAS BEING LIFTED, A SMALL TEAR IN THE INFERIOR FLAP EDGE IN THE AREA OF THE VGB WAS NOTED. THE SURGEON WAS ABLE TO LIFT FLAP BUT NOTED IT FELT THIN. THE PROCEDURE WAS COMPLETE WITH NO FURTHER COMPLICATIONS. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316271 WAVELIGHT FS200 FEMTOSECOND LASER POWERED LASER SURGICAL INSTRUMENT GEX WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other