BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 6590722 · Received May 25, 2017

    Report

    Report Number
    3003288808-2017-01229
    Event Type
    Injury
    Date Received
    May 25, 2017
    Date of Event
    March 1, 2017
    Report Date
    August 4, 2017
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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).

    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¿S ACCEPTANCE CRITERIA. LOG FILE REVIEW SHOWS THAT THE INCLINED OFFSET WAS CHANGED FROM +35UM BY Z-OFFSET -505UM TO +25UM BY Z-OFFSET -520UM DURING PM (PREVENTIVE MAINTENANCE) AND THEN IT WAS CHANGED FROM +25UM BY Z-OFFSET -520UM TO +23UM BY Z-OFFSET -510UM DURING ANOTHER PM A MONTH LATER. THE CHANGE OF OFFSET AT FIRST PM VISIT MAY HAVE LEAD TO A THINNER FLAP. THE ROOT CAUSE FOR RAINBOW GLARE COULD NOT BE IDENTIFIED CONCLUSIVELY. RAINBOW GLARE IS A KNOWN SIDE EFFECT OF FEMTO TREATMENTS AND DESCRIBED IN COMPANY PROCEDURE MANUAL. RAINBOW GLARE IS KNOWN TO APPEAR IN THIN CUTS MORE OFTEN WHEN COMPARED (B)(4).

    Description of Event or Problem · 1

    A RISK MANAGER REPORTED A PATIENT WITH RAINBOW GLARE IN THE RIGHT EYE ONE WEEK POST UNEVENTFUL LASIK. PATIENT CONTINUES TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371394 WAVELIGHT FS200 FEMTOSECOND LASER POWERED LASER SURGICAL INSTRUMENT GEX WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other