BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 6719914 · Received July 17, 2017

    Report

    Report Number
    3003288808-2017-01647
    Event Type
    Injury
    Date Received
    July 17, 2017
    Date of Event
    June 23, 2017
    Report Date
    October 5, 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

    A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT: LASER WAS SUCCESSFULLY VERIFIED PRIOR TO AND AFTER THE DAY OF THE TREATMENT. LOGFILE REVIEW FOR THE DATE OF TREATMENT SHOWS NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO REPORTED EVENT. THE TREATMENTS WERE COMPLETED TO 100% AND ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS DURING TREATMENTS AT THIS DAY. PATIENT DATA SHOWS OPAQUE BUBBLE (OBL) CREATION AT THE SIDE-CUT AREA STARTING AT 2 O'CLOCK POSITION TO 5 O'CLOCK POSITION. THE CREATION OF THE OPAQUE BUBBLE LAYER (OBL) IS KNOWN SIDE EFFECT OF FEMTO TECHNOLOGY. THE COUNTER MEASURE INCORPORATED WITH THE LASER IS THE CANAL. HOWEVER IF THE CANAL IS HINDERED FROM WORKING BY THE STRUCTURE OF THE CORNEA, OBL CAN STILL APPEAR. THE SURGEON, HOWEVER, HAS FULL VISIBILITY DURING THE CUT PROCESS AND CAN EITHER PAUSE OR STOP THE CUT IF INDICATED. THE CONTRIBUTION OF THE LASER TO THIS SPECIFIC INCIDENT IS GIVEN BUT OBL IS A KNOWN SIDE EFFECT THAT IS MANAGEABLE BY VARIOUS MEANS EVEN AFTER APPEARANCE. NO TECHNICAL ROOT CAUSE WAS IDENTIFIED AS THE PRODUCT WAS FOUND TO BE WITHIN SPECIFICATIONS. THE ROOT CAUSE COULD BE APPEARANCE OF THE OBL THAT COULD CAUSE AN INCOMPLETE FLAP INDIRECTLY IF THE SURGEON DID NOT MANAGE THE APPEARANCE OF OBL. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    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. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY'S ACCEPTANCE CRITERIA. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECHNICIAN REPORTED DURING A LEFT EYE LASER ASSISTED FLAP CREATION, THERE WAS A WATERY COBBLE STONE APPEARANCE HALF WAY TOWARDS THE INFERIOR END OF THE FLAP. THE SIDE CUT NASALLY WAS DIFFICULT TO LIFT AND A FORCEPS WAS USED TO HELP LIFT THE FLAP. THE BED APPEARED NORMAL ALL THE WAY THROUGH AND THE DOCTOR WAS ABLE TO COMPLETE THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500913 WAVELIGHT FS200 FEMTOSECOND LASER POWERED LASER SURGICAL INSTRUMENT GEX WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention