BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 7659938 · Received July 3, 2018

    Report

    Report Number
    3003288808-2018-01219
    Event Type
    Injury
    Date Received
    July 3, 2018
    Report Date
    November 1, 2018
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HOME HEALTH AIDE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORD REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. 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

    A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE LASER WAS SUCCESSFULLY VERIFIED PRIOR TO THE TREATMENT. NO TECHNICAL ROOT CAUSE WAS IDENTIFIED AS THE PRODUCT WAS FOUND TO BE WITHIN SPECIFICATIONS. THE CONTRIBUTING FACTORS OF DIFFUSE LAMELLAR KERATITIS COULD BE STERILIZATION OF INSTRUMENTS, SURGICAL TECHNIQUES, PRE AND POST-OPERATIVE MEDICATIONS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED HAVING THREE PATIENTS APPROXIMATELY THREE MONTHS PRIOR WHO EXPERIENCED DIFFUSE LAMELLAR KERATITIS FOLLOWING REFRACTIVE TREATMENT. ADDITIONAL INFORMATION RECEIVED; THE SITE IS UNABLE TO PROVIDE SPECIFICS ON THE PATIENTS AT THIS TIME. THESE PATIENTS ARE CO-MANAGED AND SEEN AT THEIR OPTOMETRIST OFFICE FOR POST OPERATIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501282 WAVELIGHT FS200 FEMTOSECOND LASER POWERED LASER SURGICAL INSTRUMENT GEX WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other