CLARITY IIRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08800291820040), received between May 22, 2026 and Aug 3, 2026 — classified as 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Environmental Particulates” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Use of Device Problem

  It was reported that patient experienced a burn on the chin following a treatment using Clarity II.Cynosure Lutronic Technology (CLT) Clinical team contacted the Site to investigate the event. CLT Clinical determined user error was involved. The provider treated the patient with three different treatments in the same day one after another with no post cooling between treatments. Provider treated first for Rosacea, then facial vessels, then facial toning. Per CLT Clinical assessment, "When the provider was pulsing on the chin for facial vessels she may have potentially pulsed to close together causing a possible overlap of treatment. The provider's pulse count for the vessels alone was at a high count of 152. Wrong ICD was also used. Then adding other treatments increased the amount of heat in the treatment areas which potentially lead to the burns. The QSG states: For small lesions or vessels located close together, avoid treating within 1 mm of an adjacent area. When treating vascular lesions with combined laser revitalization toning technique, treating the vessel first is recommended, followed by the laser toning procedure in the same session. Cooling is required between these pr

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 50122842 ↗
• InjuryAug 3, 2026Use of Device Problem

  It was reported that patient experienced a burn on the chin following a treatment using Clarity II.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 50122168 ↗
• MalfunctionJun 26, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026 CYNOSURE LUTRONIC BECAME AWARE OF A CLARITY II SPARKING DURING TREATMENT. TREATMENT CLINIC RELAYED SEEING A SPARK AND HEARING IT. THIS OCCURRED WITH THREE PATIENTS DURING SEPARATE TREATMENTS USING ICD 10/10/10 SETTINGS. ONE OUT OF THREE OF THE PATIENTS EXPERIENCED A BLISTER POST TREATMENT. IT WAS NOTED THAT THE DEVICE IS ECO-FRIENDLY; HOWEVER, THE TREATMENT CLINIC REPORTED THAT THEY MAY HAVE BEEN USING A CRYOGEN CANISTER WITH A RED LID, WHICH CONTAINS A NON-ENVIRONMENTALLY FRIENDLY CRYOGEN. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM CONTACTED THE TREATMENT CLINIC ON (B)(6) 2026 AND CONFIRMED THAT THE TREATMENT PARAMETERS USED WERE WITHIN THE RECOMMENDED CLINICAL GUIDELINES OF THE QUICKSTART GUIDE (QSG). THIS WAS THE PATIENT'S SECOND REPORTED TREATMENT; THE FIRST TREATMENT WAS PERFORMED ON (B)(6) 2026 WITH TREATMENT PARAMETERS USED ALSO TO BE WITHIN RECOMMENDED CLINICAL LIMITS. A TEST SPOT WAS REPORTEDLY TAKEN PRIOR TO THE START OF TREATMENT AND THE TREATMENT CLINIC REPORTED CLEANSING THE PATIENT'S SKIN BEFORE TREATMENT WITH 70% ISOPROPYL ALCOHOL. THE TREATMENT CLINIC REPORTED THAT THE PATIENT DID NOT HAVE ANY RECENT SUN EXPOSURE THAT WOULD AFFECT THE TREATMENT.

  Patient problems: Blister

  MAUDE report 25635262 ↗
• MalfunctionJun 25, 2026Adverse Event Without Identified Device or Use Problem

  ON 26 MAY 2026, CYNOSURE LUTRONIC BECAME AWARE OF A CLARITY II SPARKING DURING TREATMENT. TREATMENT CLINIC RELAYED SEEING A SPARK AND HEARING IT. THIS OCCURRED WITH THREE PATIENTS DURING SEPARATE TREATMENTS USING ICD 10/10/10 SETTINGS. ONE OUT OF THREE OF THE PATIENTS EXPERIENCED A BLISTER POST TREATMENT. IT WAS NOTED THAT THE DEVICE IS ECO-FRIENDLY; HOWEVER, THE TREATMENT CLINIC REPORTED THAT THEY MAY HAVE BEEN USING A CRYOGEN CANISTER WITH A RED LID, WHICH CONTAINS A NON-ENVIRONMENTALLY FRIENDLY CRYOGEN.

  Patient problems: Blister

  MAUDE report 25626529 ↗
• MalfunctionJun 25, 2026Adverse Event Without Identified Device or Use Problem

  CYNOSURE LUTRONIC BECAME AWARE OF A CLARITY II SPARKING DURING TREATMENT. TREATMENT CLINIC RELAYED SEEING A SPARK AND HEARING IT. THIS OCCURRED WITH THREE PATIENTS DURING SEPARATE TREATMENTS USING ICD 10/10/10 SETTINGS. IT WAS NOTED THAT THE DEVICE IS ECO-FRIENDLY; HOWEVER, THE TREATMENT CLINIC REPORTED THAT THEY MAY HAVE BEEN USING A CRYOGEN CANISTER WITH A RED LID, WHICH CONTAINS A NON-ENVIRONMENTALLY FRIENDLY CRYOGEN. A MEMBER OF THE CYNOSURE LUTRONIC (CL) CLINICAL TEAM CONTACTED THE TREATMENT CLINIC ON 26 MAY 2026 TO FURTHER INVESTIGATE THE INCIDENT. ON 2 JUNE 2026, CL CLINICAL BECAME AWARE THAT PATIENT EXPERIENCED A BURN. NO ADDITIONAL INFORMATION OR IMAGES WAS PROVIDED ALTHOUGH REQUESTED. BURNS ARE AN EXPECTED SIDE EFFECT FROM SUCH TREATMENTS. ON 23 JUNE 2026 A TRAINED CL FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE TO PERFORM A DEVICE EVALUATION. FSE PERFORMED A SYSTEM EVALUATION AND FUNCTIONAL CHECK. HANDPIECE AND FIBER WERE THEN INSPECTED. FSE CHECKED THE ENERGY ON BOTH ALEX AND YAG USING 18MM. FSE ALSO INSPECTED AND TESTED 3MM/5MM, 8MM/10MM/12MM CARTRIDGES ON CUSTOMER'S REPORTED FLUENCE SETTING. FSE CONFIRMS NO ISSUES WERE FOUND AND LASER ENERGY WAS WITHIN SPECIFICATION.

  Patient problems: Burn(s)

  MAUDE report 25623500 ↗
• MalfunctionJun 25, 2026Adverse Event Without Identified Device or Use Problem

  ON 26 MAY 2026 CYNOSURE LUTRONIC BECAME AWARE OF A CLARITY II SPARKING DURING TREATMENT. TREATMENT CLINIC RELAYED SEEING A SPARK AND HEARING IT. THIS OCCURRED WITH THREE PATIENTS DURING SEPARATE TREATMENTS USING ICD 10/10/10 SETTINGS. ONE OUT OF THREE OF THE PATIENTS EXPERIENCED A BLISTER POST TREATMENT. IT WAS NOTED THAT THE DEVICE IS ECO-FRIENDLY; HOWEVER, THE TREATMENT CLINIC REPORTED THAT THEY MAY HAVE BEEN USING A CRYOGEN CANISTER WITH A RED LID, WHICH CONTAINS A NON-ENVIRONMENTALLY FRIENDLY CRYOGEN. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM CONTACTED THE TREATMENT CLINIC ON 26 MAY 2026 AND CONFIRMED THAT THE TREATMENT PARAMETERS USED WERE WITHIN THE RECOMMENDED CLINICAL GUIDELINES OF THE QUICKSTART GUIDE (QSG). THIS WAS THE PATIENT'S SECOND REPORTED TREATMENT; THE FIRST TREATMENT WAS PERFORMED ON (B)(6) 2026 WITH TREATMENT PARAMETERS USED ALSO TO BE WITHIN RECOMMENDED CLINICAL LIMITS. A TEST SPOT WAS REPORTEDLY TAKEN PRIOR TO THE START OF TREATMENT AND THE TREATMENT CLINIC REPORTED CLEANSING THE PATIENT'S SKIN BEFORE TREATMENT WITH 70% ISOPROPYL ALCOHOL. THE TREATMENT CLINIC REPORTED THAT THE PATIENT DID NOT HAVE ANY RECENT SUN EXPOSURE THAT WOULD AFFECT THE TREATMENT.

  Patient problems: Blister

  MAUDE report 25623451 ↗
• MalfunctionJun 25, 2026Adverse Event Without Identified Device or Use Problem

  ON 26 MAY 2026, CYNOSURE LUTRONIC BECAME AWARE OF A CLARITY II SPARKING DURING TREATMENT. TREATMENT CLINIC RELAYED SEEING A SPARK AND HEARING IT. THIS OCCURRED WITH THREE PATIENTS DURING SEPARATE TREATMENTS USING ICD 10/10/10 SETTINGS. ONE OUT OF THREE OF THE PATIENTS EXPERIENCED A BLISTER POST TREATMENT. IT WAS NOTED THAT THE DEVICE IS ECO-FRIENDLY; HOWEVER, THE TREATMENT CLINIC REPORTED THAT THEY MAY HAVE BEEN USING A CRYOGEN CANISTER WITH A RED LID, WHICH CONTAINS A NON-ENVIRONMENTALLY FRIENDLY CRYOGEN.

  Patient problems: Blister

  MAUDE report 25623164 ↗
• InjuryJun 15, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURN ON THE RIGHT NOSTRIL FOLLOWING A LASER VASCULAR TREATMENT USING CLARITY II. CYNOSURE LUTRONIC TECHNOLOGY (CLT) CLINICAL TEAM CONTACTED THE SITE TO INVESTIGATE THE EVENT. CLT CLINICAL DETERMINED THE EVENT TO BE USER ERROR. PHOTOS OF THE PATIENT'S INJURY WAS ALSO PROVIDED. THE TREATMENT SETTINGS USED WERE OUTSIDE THE RECOMMENDED RANGE. FOR THE 1064 NM WAVELENGTH WITH THE 5 MM HANDPIECE, THE RECOMMENDED PULSE DURATION IS 50-30 MS. PER CLT CLINICAL, "THE PULSE DURATION USED DURING THIS TREATMENT WAS 15 MS, WHICH LIKELY CONTRIBUTED SIGNIFICANTLY TO THE REPORTED SIDE EFFECTS." THE RECOMMENDED FLUENCE FOR THE 1064 NM, 5 MM HANDPIECE IS 90-120 J/CM², WHEREAS THE FLUENCE USED WAS 140 J/CM², CONSIDERABLY EXCEEDING THE MAXIMUM RECOMMENDED VALUE. NO PATCH TEST WAS PERFORMED PRIOR TO TREATMENT, DESPITE PATCH TESTING BEING HIGHLY RECOMMENDED BEFORE PROCEEDING. IN ADDITION, 25 PULSES WERE DELIVERED TO THE NOSTRIL AREA USING THE 5 MM HANDPIECE. CONSIDERING THE SMALL TREATMENT SURFACE AND THE RECOMMENDATION TO AVOID PULSE OVERLAP, THE HIGH NUMBER OF PULSES SUGGESTS THAT SIGNIFICANT OVERLAP OR DOUBLE PULSING MAY HAVE OCCURRED, FURTHER CONTRIBUTING TO

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 25503868 ↗
• InjuryJun 15, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURN ON THE RIGHT NOSTRIL FOLLOWING A LASER VASCULAR TREATMENT USING CLARITY II.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 25503805 ↗
• MalfunctionJun 11, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURN POST ANGIOMA TREATMENT ON THE ABDOMEN WITH A CLARITY II DEVICE. A MEMBER OF THE CYNOSURE LUTRONIC TECHNOLOGY (CLT) CLINICAL TEAM CONTACTED THE TREATMENT SITE FOR ADDITIONAL INFORMATION. DURING TREATMENT, THE PATIENT DID NOT REPORT ANY PAIN, HEAT, OR BURNING SENSATION. OTHER ANGIOMAS IN THE AREA WERE TREATED WITHOUT INCIDENT. DURING TREATMENT IT WAS REPORTED THERE WAS A SPARK SEEN AND BLACK SOOT WAS OBSERVED ON THE PATIENT'S SKIN; THE SOOT WAS CLEANED AWAY WITH COLD WATER. THE SITE REPORTED THAT THE ICD SETTINGS USED WERE 10/20/10, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED SPARK AND PATIENT BURN. PER CURRENT CLINICAL TREATMENT GUIDELINES IN THE QUICKSTART GUIDE (QSG), IT IS RECOMMENDED FOR VASCULAR OR ANGIOMA TREATMENT THAT THE ICD SETTINGS BE SET TO 10/10/10. ADDITIONALLY, REVIEW OF THE TREATMENT PARAMETERS USED OBSERVED THAT THE FLUENCE USED WAS HIGHER THAN THE RECOMMENDED PUBLISHED PARAMETERS OF THE QSG. IT IS UNKNOWN IF THE HIGH FLUENCE CONTRIBUTED TO THE REPORTED ISSUE. THE MEDICAL DIRECTOR REVIEWED THE IMAGES PROVIDED BY THE TREATMENT SITE OF THE PATIENT'S BURN. THESE IMAGES WERE REVIEWED BY THE CLT MEDICAL DIRECTOR WHO DETERM

  Patient problems: Burn(s)

  MAUDE report 25476988 ↗
• MalfunctionJun 11, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A BURN POST ANGIOMA TREATMENT ON THE ABDOMEN WITH A CLARITY II DEVICE.

  Patient problems: Burn(s)

  MAUDE report 25472940 ↗
• MalfunctionJun 8, 2026Environmental Particulates

  IT WAS REPORTED THAT SPARK AND SOOT OCCURRED DURING A LEG VESSEL TREATMENT USING CLARITY II.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25437847 ↗
• MalfunctionJun 8, 2026Environmental Particulates

  IT WAS REPORTED THAT SPARK AND SOOT OCCURRED DURING A LEG VESSEL TREATMENT USING CLARITY II. CYNOSURE LUTRONIC TECHNOLOGY (CLT) CLINICAL TEAM CONTACTED THE SITE TO INVESTIGATE THE EVENT. CLT CLINICAL CONFIRMED NO INJURIES HAD OCCURRED. PARAMETERS USED WERE WITHIN PUBLISHED GUIDELINES, INCLUDING ICD AT 10/10/10. DEVICE EVALUATION WAS NOT PERFORMED SINCE SPARK AND SOOT OBSERVATION IS A KNOWN OCCURRENCE. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25435929 ↗
• MalfunctionMay 27, 2026Leak/Splash

  IT WAS REPORTED THAT DURING CLARITY II TREATMENT THE CRYOGEN WAS SPRAYING CONTINUOUSLY AND RESOLVED ON ITS OWN AFTERWARDS. PROVIDER ALSO MENTIONED THAT THEY WERE NOT SEEING RESULTS WHEN PERFORMING VASCULAR TREATMENTS AND LASER WAS NOT CLEARING THE VEINS CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306632 ↗
• MalfunctionMay 27, 2026Leak/Splash

  IT WAS REPORTED THAT DURING CLARITY II TREATMENT THE CRYOGEN WAS SPRAYING CONTINUOUSLY AND RESOLVED ON ITS OWN AFTERWARDS. PROVIDER ALSO MENTIONED THAT THEY WERE NOT SEEING RESULTS WHEN PERFORMING VASCULAR TREATMENTS AND LASER WAS NOT CLEARING THE VEINS CORRECTLY. CYNOSURE LUTRONIC (CL) CLINICAL TEAM CONTACTED THE SITE TO INVESTIGATE THE EVENT. CL CLINICAL CONFIRMED THAT NO INJURY HAD OCCURRED. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT PROVIDER SITE TO PERFORM A DEVICE EVALUATION. FSE PERFORMED METER VERIFICATION IN ALL OPERATIVE MODES. ALL AVAILABLE WINDOWS, FIBERS, AND OPTICS ON ALL CARTRIDGES WERE INSPECTED. ICD OPERATION WAS VERIFIED. COOLANT LEVEL WAS CHECKED, AND THE AIR FILTER WAS CLEANED. BURN SAMPLES WERE RECORDED OF ALL CARTRIDGE SIZES. FULL FUNCTION TEST IN ALL OPERATIVE MODES. DEVICE CONFIRMED TO BE OPERATING WITHIN CYNOSURE LUTRONIC PUBLISHED SPECIFICATIONS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25302570 ↗
• InjuryMay 26, 2026Appropriate Device Problem Term/Code Not Available

  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.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 25280393 ↗
• InjuryMay 22, 2026Appropriate Device Problem Term/Code Not Available

  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. 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 P

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 25259806 ↗