BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 8980900 · Received September 10, 2019

    Report

    Report Number
    3003288808-2019-00890
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    May 7, 2019
    Report Date
    November 14, 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 PRIOR TO AND AFTER THE DAY OF TREATMENT. REVIEW OF THE LOGFILE FOR THE DAY OF TREATMENT SHOWED 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 CHECKS BEFORE THIS PATIENT. THE ENERGY WAS STABLE DURING THE WHOLE DAY. THE USER TREATED THE PATIENT'S RIGHT EYE TWICE. FOR BOTH TREATMENTS THE VALUE FOR SPHERE, CYLINDER AND GENERAL ROTATION (AXIS) WAS ZERO BUT THE USER TREATED WITH AN SPECIAL SHOOT LIST. FOR THE FIRST TREATMENT OF THE RIGHT EYE, THE SURGEON TREATED WITH THE SHOOT LIST. FOR THE SECOND TREATMENT OF THE PATIENT'S RIGHT EYE, THE SURGEON TREATED WITH THE A DIFFERENT SHOOT LIST. THE PATIENT'S LEFT EYE WAS NOT TREATED. CLINICAL APPLICATIONS SPECIALIST (CAS) REVIEW SHOWED: THE TREATMENT REPORT SHOWED TWO COMPLETED PHOTOTHERAPEUTIC KERATECTOMY (PTK) PROCEDURES. PTK IS NOT DESIGNED FOR REFRACTIVE CORRECTION SO IF YOU PERFORM A PTK YOU ALWAYS HAVE TO EXPECT CHANGES IN REFRACTIVE OUTCOMES ESPECIALLY WITH A BIG AMOUNT OF REMOVED TISSUE. THERE WILL BE AN UNPREDICTED BIOMECHANICAL CHANGE AND EPITHELIUM REGROW HAPPEN. ADDITIONALLY IF YOU HAVE PREVIOUS SCARS, THE EPITHELIUM ABOVE AND AROUND THE SCAR IS DIFFERENT IN THICKNESS AND THE LASER ABLATION ALSO WILL BE DIFFERENT IN THE SCARRED STROMA AND THEREFORE, THE ROOT CAUSE OF THIS UNEXPECTED REFRACTIVE OUTCOME IS NOT RELATED TO THE DEVICE BUT RATHER TO THE APPLIED TREATMENT MODE. ROOT CAUSE IS USER HANDLING. LOGFILE AND CAS REVIEW SHOWED THE USER PERFORMED PTK. CAS STATED IF YOU PERFORM A PTK YOU ALWAYS HAVE TO EXPECT CHANGES IN REFRACTIVE OUTCOMES ESPECIALLY WITH A BIG AMOUNT OF REMOVED TISSUE. THERE WILL BE AN UNPREDICTED BIOMECHANICAL CHANGE AND EPITHELIUM REGROW HAPPEN. 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 WAS REVIEWED. 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 PHYSICIAN REPORTED THAT A PATIENT ENDED UP HIGHLY HYPEROPIC AFTER PHOTO THERAPEUTIC KERATECTOMY (PTK). THIS MAY NOT HAVE BEEN PREDICTABLE BASED ON THE PATIENT¿S PRE-OP STATUS. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT HAD A PREVIOUS KERATITIS SCAR THAT THE SURGEON WAS TRYING TO GET UNDER WITH PTK. THERE WAS STILL SOME RESIDUAL SCARRING (APPROXIMATELY 50 MICRONS) BUT IS MOSTLY GONE. THE PATIENT IS BEING SENT TO TRY RIGID GAS PERMEABLE CONTACT LENS. THE SURGEON IS WONDERING IF IT COULD BE FROM LENGTH OF TIME USE OF CYTOTOXIC DRUG DURING THE PROCEDURE. THE SURGEON IS THINKING IT MUST HAVE TO DO WITH SURGERIES THAT 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 AC AND ANOTHER MANUFACTURER REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778823 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention