BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 6561580 · Received May 11, 2017

    Report

    Report Number
    3003288808-2017-01108
    Event Type
    Injury
    Date Received
    May 11, 2017
    Report Date
    August 2, 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
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. LOG FILE REVIEW SHOWS ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS FOR THE RESPECTIVE TREATMENT. TECHNICAL SERVICE VERIFIED THE SYSTEM AND SHOWED THAT THE INCLINED OFFSET WAS SET FROM 54 TO 42 DURING A PREVIOUS SERVICE VISIT WHICH MEANS THAT THE FLAPS ARE ABOUT 10 MICRONS THINNER. THE INCLINED OFFSET WAS RESET TO 50 ON THE NEXT SERVICE VISIT. 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 ROOT CAUSE FOR RAINBOW GLARE AND FILAMENTS COULD NOT BE IDENTIFIED CONCLUSIVELY. RAINBOW GLARE IS A KNOWN SIDE EFFECT OF FEMTO TREATMENTS AND DESCRIBED IN THE PROCEDURE MANUAL. RGB IS KNOWN TO APPEAR IN THIN CUTS MORE OFTEN WHEN COMPARED TO THICK FLAPS. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH RAINBOW GLARE OF THE RIGHT EYE FOLLOWING LASIK TREATMENT. ADDITIONAL INFORMATION RECEIVED INDICATES THE FLAP CREATED WAS THIN. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343550 WAVELIGHT FS200 FEMTOSECOND LASER POWERED LASER SURGICAL INSTRUMENT GEX WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other