BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARITY II

    MDR report key: 25280393 · Received May 26, 2026

    Report

    Report Number
    3021199089-2026-00035
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 26, 2026
    Manufacturer
    CYNOSURE LUTRONIC TECHNOLOGY CORPORATION
    Product Code
    GEX
    UDI-DI
    08800291820040
    PMA / PMN Number
    K183566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CYNOSURE LUTRONIC CLINICAL TEAM FOLLOWED UP WITH THE TREATMENT CLINIC FOR ADDITIONAL INFORMATION. IMAGES WERE PROVIDED AND REVIEWED BY CYNOSURE LUTRONIC MEDICAL DIRECTOR. THE CYNOSURE LUTRONIC MEDICAL DIRECTOR RECOGNIZED A FULL THICKNESS BURN ON THE MID CHEEK WITH LOSS OF EPIDERMIS, DERMIS AND SUBCUTANEOUS TISSUES. HE STATED THAT A SCAR IS INEVITABLE, AND IT CANNOT BE PREVENTED. HE ALSO RECOMMENDED THAT THE WOUND NEEDS TO BE CLEANED DAILY AND MANAGED CLOSELY FOR APPROPRIATE CARE AND THE PATIENT TO BE EVALUATED BY A BURN SPECIALIST OR A DERMATOLOGIST. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER PAID A VISIT TO THE TREATMENT FACILITY FOR A DEVICE EVALUATION. DURING THIS TIME THE DEVICE WAS FULLY INSPECTED, AND THERE WAS NO APPARENT DAMAGE TO THE DEVICE BUT THERE WERE A COUPLE PARTS THAT WERE DIRTY BUT THEY WERE CLEANED. THE DEVICE WAS ALSO SUBJECTED TO A FULL DEVICE EVALUATION INCLUDING FULL FUNCTIONALITY TESTING WITH PASSING RESULTS. THE ENERGY LEVELS AND SETTINGS WERE CHECKED AND VERIFIED TO BE WORKING WITHIN ITS SPECIFICATIONS. AT THIS TIME, THE EXACT ROOT CAUSE OF THE EVENT REMAINS UNDETERMINED. WHILE THE TREATMENT PARAMETERS WERE LARGELY WITHIN RECOMMENDED RANGES, FACTORS INCLUDING THE ABSENCE OF TEST SPOTS AND DEVIATION IN HANDPIECE SIZE WERE IDENTIFIED; HOWEVER, A DEFINITIVE CAUSAL RELATIONSHIP CANNOT BE ESTABLISHED. THIS EVENT IS REPORTABLE UNDER FDA MEDICAL DEVICE REPORTING REQUIREMENTS (21 CFR PART 803), AS THE REPORTED INJURY INVOLVED A SERIOUS INJURY REQUIRING MEDICAL INTERVENTION WITH LIKELY PERMANENT IMPAIRMENT DUE TO SCARRING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BURN ON THE FACE AFTER UNDERGOING FACIAL TREATMENTS WITH THE CLARITY II DEVICE. THE PATIENT WAS EVALUATED BY A PHYSICIAN, DIAGNOSED WITH A FACIAL BURN, AND PRESCRIBED A TOPICAL ANTIBIOTIC AS PREVENTATIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492173 CLARITY II CLARITY II GEX CYNOSURE LUTRONIC TECHNOLOGY CORPORATION 08800291820040

    Patients

    Seq Age Sex Outcome Treatment
    1