BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARITY II

    MDR report key: 25242828 · Received May 21, 2026

    Report

    Report Number
    1222993-2026-00034
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 21, 2026
    Manufacturer
    CYNOSURE LUTRONIC TECHNOLOGY CORPORATION
    Product Code
    GEX
    UDI-DI
    08809447653723
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SPARK AND SOOT OCCURRED DURING A LASER HAIR REMOVAL TREATMENT ON THE FACE USING CLARITY II. NO PATIENT INJURY WAS REPORTED. CYNOSURE LUTRONIC CLINICAL TEAM CONTACTED THE SITE TO INVESTIGATE THE EVENT. CYNOSURE LUTRONIC CLINICAL DETERMINED THE EVENT TO BE INCONCLUSIVE. SITE FAILED TO RESPOND TO MULTIPLE CONTACT ATTEMPTS AND THEREFORE ADDITIONAL DETAILS COULD NOT BE OBTAINED. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE TO PERFORM A DEVICE EVALUATION. CARTRIDGES 22, 18, AND 15 LENS WERE SPOTTED AND DAMAGED. WINDOW ON HANDPIECE WAS SPOTTED AND NEEDED REPLACEMENT. THE SMALL O-TYPE TIP THAT WAS USED FOR TREATMENT WAS DAMAGED WITH A SMALL BURN SPOT. TARGET OUTPUT WAS 45.62J BUT ACTUAL OUTPUT WAS 41.07J. FSE SUSPECT ENERGY LOSS FROM LENS DEGRADATION. ENERGY OUTPUTS FOR 1064NM AND 755NM WERE ALL WITHIN SPECIFICATION. FSE ORDERED REPLACEMENTS FOR DAMAGED LENS, HANDPIECE, AND O-TYPE TIP. SPARK THAT OCCURRED IS LIKELY RELATED TO THE CRYOGEN INVOLVED. CRYOGEN IS APPLIED TO THE TREATMENT SITE DURING VASCULAR TREATMENT TO PRECOOL THE SKIN. THE CRYOGEN BEGINS TO VAPORIZE FROM THE SURFACE OF THE SKIN SHORTLY AFTER CONTACT. THE LASER FIRES ONTO THE SURFACE OF THE SKIN AFTER A DELAY TIME. THE SPARK/IGNITION EVENTS OCCUR WHEN RESIDUAL CRYOGEN VAPORS REMAINING ON THE SKIN SURFACE INTERACT WITH THE HIGH-ENERGY 1064 NM LASER FLUENCE. LONGER PRE-COOLING AND DELAY TIMES INCREASE THE LIKELIHOOD OF UNEVEN VAPOR ACCUMULATION, THEREBY ELEVATING THE RISK OF IGNITION. THIS CAN BE OBSERVED AS A SPARK AND CAN RESULT IN TOPICAL BURN. TO REDUCE THE PROBABILITY OF REOCCURRENCE THE TREATMENT PROVIDER WAS INFORMED THAT VASCULAR LESION TREATMENTS OVER 60 J/CM2 SHOULD UTILIZE AN ICD SETTING OF 10/10/10 PER THE RECENT UPDATE. A CUSTOMER LETTER HAS SINCE GONE OUT TO NOTIFY CUSTOMERS OF THIS RECOMMENDED SETTING UPDATE. THE EVENT IS REPORTABLE PER FDA MEDICAL DEVICE REPORTING TITLE 21 CFR PART 803 SINCE AN OBSERVED MALFUNCTION OCCURRED AND COULD LIKELY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214522 CLARITY II CLARITY II GEX CYNOSURE LUTRONIC TECHNOLOGY CORPORATION 08809447653723

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown