BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 9069343 · Received September 16, 2019

    Report

    Report Number
    3003288808-2019-00898
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    May 7, 2019
    Report Date
    December 24, 2019
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT: LASER WAS SUCCESSFULLY VERIFIED AFTER TREATMENT DATE. REVIEW OF THE LOGFILE FOR THE DAY OF TREATMENT SHOWER DURING THE START-UP IN THE MORNING, THE SYSTEM PASSED ALL INITIALIZATION STEPS WITHOUT ANY RELEVANT DEVIATION. THE USER PERFORMED THE GAS CHANGE, SKIPPED THE SCANNER TEST AND PERFORMED THE NECESSARY ENERGY CHECK, EYETRACKER AND FLUENCE TEST WITHOUT ANY ISSUE. THE LOGFILE SHOWED SUCCESSFULLY PERFORMED TREATMENTS. THE USER PERFORMED AN ENERGY CHECK BEFORE THIS PATIENT. THE ENERGY WAS STABILE DURING THE WHOLE DAY. THE USER TREATED THE PATIENT'S LEFT EYE TWICE. FOR BOTH TREATMENTS, THE VALUE FOR SPHERE, CYLINDER AND GENERAL ROTATION (AXIS) WAS 0, BUT THE USER TREATED WITH AN SPECIAL SHOOTLIST. FOR THE FIRST TREATMENT OF THE LEFT EYE, THE SURGEON TREATED WITH THE SHOOTLIST AND FIRED SHOTS. FOR THE SECOND TREATMENT OF THE PATIENT'S LEFT EYE, THE SURGEON TREATED WITH A DIFFERENT SHOOTLIST AND A DIFFERENT NUMBER OF FIRED SHOTS. THE PATIENT'S RIGHT EYE WAS NOT TREATED. THE TREATMENT REPORT SHOWED TWO COMPLETED PHOTO THERAPEUTIC KERATECTOMY (PTK) PROCEDURES. THE ROOT CAUSE IS DUE TO USER HANDLING. 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 RECORD (DHR) FOR THE DEVICE HAS BEEN REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY'S ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT A PATIENT ENDED UP WITH A SIGNIFICANT HYPEROPIC SHIFT AFTER PHOTO THERAPEUTIC KERATECTOMY (PTK). THE PATIENT HAD STROMAL SCARS FROM POSSIBLE VIRAL KERATITIS OVER TEN YEARS AGO. BILATERAL SUPERFICIAL KERATECTOMIES WERE PERFORMED. THE RIGHT EYE WAS SUCCESSFUL BUT THE LEFT EYE WAS LESS SO. THE SCARS ARE NOW MOSTLY CLEAR ACROSS THE PUPIL AREA BUT THERE IS STILL IRREGULAR ASTIGMATISM OF A DIFFERENT TYPE COMPARED TO BEFORE PROCEDURE SO THE PATIENT HAS BEEN SENT TO AN OPTOMETRIST FOR RIGID GAS PERMEABLE LENSES. THE PATIENT'S HYPEROPIC SHIFT WAS LESS SIGNIFICANT BUT STILL NEARLY FOUR DIOPTERS. THE SURGEON IS WONDERING IF IT COULD BE FROM USING OF LENGTH OF TIME USING OF CYTOTOXIC DRUG DURING THE PROCEDURE. THE SURGEON IS THINKING IT MUST HAVE TO DO WITH SURGERIES WERE PERFORMED FOR THESE TWO PATIENTS THAT HAD SIMILAR TREATMENTS AND SIMILAR RESPONSES. THERE ARE TWO RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT LG AND ANOTHER MANUFACTURER REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862877 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention