CLARITY II CLARITY II ICDRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08809447653723), received between Sep 19, 2025 and May 21, 2026 — classified as 7 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Environmental Particulates” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 27, 2026Class IIOpen, Classified

   Reports of devices sparking/popping and potentially burning patients.

   Z-1558-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Environmental Particulates

  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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242828 ↗
• MalfunctionMay 21, 2026Environmental Particulates

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25242442 ↗
• MalfunctionApr 7, 2026Environmental Particulates

  IT WAS REPORTED THAT BLACK SOOT WAS OBSERVED ON THE PATIENT'S NOSE DURING A VASCULAR TREATMENT USING CLARITY II. SITE CONFIRMED THAT NO PATIENT INJURIES OCCURRED. SITE HAD RELAYED THAT THEY USED NEWLY UPDATED ICD SETTINGS, BUT SOOT STILL OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800701 ↗
• MalfunctionApr 7, 2026Environmental Particulates

  IT WAS REPORTED THAT BLACK SOOT WAS OBSERVED ON THE PATIENT'S NOSE DURING A VASCULAR TREATMENT USING CLARITY II. SITE CONFIRMED THAT NO PATIENT INJURIES OCCURRED. SITE HAD RELAYED THAT THEY USED NEWLY UPDATED ICD SETTINGS, BUT SOOT STILL OCCURRED. ON (B)(6) 2026 A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM CONTACTED THE TREATMENT PROVIDER TO FURTHER INVESTIGATE THE EVENT. IT WAS SHARED THAT PATIENT'S LAST TWO TREATMENTS WERE PERFORMED WITH SAME SETTINGS AND WAS WELL TOLERATED. THE SETTINGS USED WERE 1064 NM, 5 MM HANDPIECE DIAMETER, 30 MS, 110 J/CM2, ICD 10/10/10, SINGLE PASS. DURING THE SAME SESSION, LASER HAIR REMOVAL WAS PERFORMED AFTERWARDS ON THE CLIENT'S EARS AND WAS WELL TOLERATED. THE DEVICE WAS THEN SWITCHED TO VASCULAR SETTINGS, INCORPORATING THE UPDATED ICD PARAMETERS. ONE PULSE WAS DELIVERED TO THE RIGHT SIDE OF THE NOSE WITHOUT ANY ISSUES. THE INCIDENT OCCURRED WHEN AN ADDITIONAL PULSE WAS APPLIED TO THE LEFT SIDE OF THE NOSE. THE TECHNICIAN NOTED A BRIGHT SPARK AT THE TIME OF TREATMENT, FOLLOWED BY THE APPEARANCE OF BLACK SOOT ON THE SKIN. ON (B)(6), 2026, SITE REPORTED THAT THE PATIENT IS PLEASED WITH THE VASCULAR IMPROVEMENT AND CONFIRMED THAT THERE WERE NO VISIB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800319 ↗
• InjuryMar 25, 2026Use of Device Problem

  IT WAS REPORTED THAT A PATIENTS EXPERIENCED ELEVATED ERYTHEMA AND DARKENING WITH POSSIBLE BLISTERS ON THE ARMS FOLLOWING PIGMENTATION TREATMENT WITH A CLARITY II DEVICE. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM MADE CONTACT WITH THE TREATMENT SITE AND DETERMINED THAT THE TREATMENT PARAMETERS USED WERE SLIGHTLY AGGRESSIVE. THE CLARITY II QUICKSTART GUIDE (QSG) PARAMETERS FOR FLUENCE ARE 12-16. ADDITIONALLY, THE QSG STATES THAT ONE PASS IS RECOMMENDED DURING TREATMENT. THE PATIENT WAS TREATED AT 16J/CM2 WHICH IS WITHIN THE RECOMMENDED GUIDELINES OF THE QSG, HOWEVER, IT WAS NOTED THAT THE FLUENCE WAS AT THE MAXIMUM AND THAT THE PATIENT WAS TREATED WITH TWO (2) PASSES, WHICH MADE THE TREATMENT PARAMETERS USED AGGRESSIVE. THIS MAY HAVE CONTRIBUTED TO THE REPORTED SIDE EFFECTS. THE PATIENT WAS PRESCRIBED AQUAPHOR, TRIAMCINOLONE AND SILVADENE AS PREVENTATIVE AND WENT TO A PLASTIC SURGEON ON THEIR OWN FOR CONSULTATION. IMAGES OF THE PATIENTS BURN WERE SENT TO THE CYNOSURE LUTRONIC MEDICAL DIRECTOR WHO STATED THAT THERE WAS EITHER AREAS THAT HAVE LOSS OF EPIDERMIS OR LOSS OF DERMAL TISSUE AND THAT THERE WAS A POSSIBILITY OF SCARRING. IT WAS RECOMMENDED THAT THE PATIENT USES A GENTLE

  Patient problems: Burn(s)

  MAUDE report 24689988 ↗
• InjuryMar 25, 2026Use of Device Problem

  IT WAS REPORTED THAT A PATIENTS EXPERIENCED ELEVATED ERYTHEMA AND DARKENING WITH POSSIBLE BLISTERS ON THE ARMS FOLLOWING PIGMENTATION TREATMENT WITH A CLARITY II DEVICE.

  Patient problems: Burn(s)

  MAUDE report 24688789 ↗
• MalfunctionMar 19, 2026Environmental Particulates

  A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT PROVIDER SITE FOR A DEVICE EVALUATION. DURING THIS TIME THE DEVICE WAS SUBJECTED TO FULL FUNCTIONALITY TESTING AND VISUAL INSPECTION WITH PASSING RESULTS. THE DEVICE WAS FOUND TO BE WORKING TO PUBLISHED SPECIFICATIONS. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM MADE CONTACT WITH THE TREATMENT PROVIDER AND REVIEWED THE TREATMENT PARAMETERS USED. IT WAS REPORTED THAT THIS WAS THE PATIENTS SECOND TREATMENT AND THE CLINICAL TEAM DETERMINED THAT THE SETTINGS USED FOR THIS TREATMENT WERE WITHIN THE RECOMMENDED RANGE OF THE QUICKSTART GUIDE (QSG). THE ICD PARAMETERS USED WERE CONSISTENT WITH THE UPDATED GUIDELINES. THE TREATMENT PROVIDER CONFIRMED THAT THE LASER TIP WAS MAINTAINED PERPENDICULAR TO THE SKINS SURFACE AT ALL TIMES DURING TREATMENT WITHOUT PULSE OVERLAPPING. THE EXACT TREATMENT DATE OF THE FIRST TREATMENT IS UNKNOWN. THIS TREATMENT UTILIZED DIFFERENT ICD SETTINGS THAT WERE CONSISTENT WITH THE QSG GUIDELINES AT THAT TIME (10/20/10 MS) AND WAS REPORTED TO BE WELL TOLERATED, WITH NO SIDE EFFECTS REPORTED. THE CLINICAL TEAM REQUESTED UPDATES ON THE PATIENTS HEALING PROGRESS, UPDATED PHOTOS, AND AD

  Patient problems: Burn(s)

  MAUDE report 24643007 ↗
• MalfunctionMar 19, 2026Environmental Particulates

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POTENTIAL LASER BURN AFTER A SPARK OCCURRED DURING LASER VASCULAR TREATMENT WITH A CLARITY II DEVICE. THE PATIENT EXPERIENCED BLISTERING AND THE SMALL O-RING TIP APPEARS TO BE BURNT.

  Patient problems: Burn(s)

  MAUDE report 24639285 ↗
• MalfunctionMar 13, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING TREATMENT SPARKS WERE COMING OUT OF THE TIP OF THE CLARITY II HANDPIECE (HP). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594004 ↗
• MalfunctionMar 13, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING TREATMENT SPARKS WERE COMING OUT OF THE TIP OF THE CLARITY II HANDPIECE (HP). THERE WAS NO PATIENT INJURY REPORTED. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER WENT TO THE TREATMENT PROVIDER SITE FOR A DEVICE EVALUATION. DURING THIS TIME, THE FSE DID NOT OBSERVE THE DEVICE SPARKING, HOWEVER, TESTING FOUND THE DEVICE WAS NOT WORKING TO THE PUBLISHED SPECIFICATIONS. THE SPOT SIZES 18 AND 25 WERE VISUALLY INSPECTED AND OBSERVED SOME DAMAGE. IT IS UNDETERMINED WHAT CAUSED THIS DAMAGE, OR IF IT CONTRIBUTED TO THE REPORTED SPARKING BUT TO CORRECT THE OBSERVATION, REPLACEMENT SPOT SIZES WERE ORDERED. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM MADE CONTACT WITH THE TREATMENT PROVIDER AND CONFIRMED THAT THERE WAS NO PATIENT INJURIES. THE TREATMENT PROVIDER REPORTED THAT THEY REPLACED THE HP WINDOW AND THE SPARKING DID NOT OCCUR AGAIN. THE TREATMENT PROVIDER REPORTED THAT THE WINDOW WAS DAMAGED, HOWEVER, THERE WAS NO IMAGE OF THE WINDOW NOR WAS IT WAS RETURNED FOR FURTHER EVALUATION. THEREFORE, IT IS UNDETERMINED IF ANY DAMAGE OR POSSIBLE PARTICULATE ON THE WINDOW CONTRIBUTED TO THE REPORTED SPARKING. TO REDUCE THE PROBABILITY OF REOCCURRENCE, THE CLEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590312 ↗
• MalfunctionMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING LASER VASCULAR TREATMENT WITH A CLARITY II DEVICE, A SPARK OCCURRED FOLLOWED BY VISIBLE BLACK "SOOT" ON THE SKIN. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT PROVIDER SITE FOR A DEVICE EVALUATION. DURING THIS TIME, THERE WAS NO EVIDENCE OF OBSERVATION OF THE DEVICE SPARKING MADE BY THE FSE. THE DEVICE WAS VISUALLY INSPECTED FOR DAMAGE, AND IT WAS OBSERVED TO HAVE DEBRIS IN THE AIR FILTER AND THE HANDPIECE (HP) FILTER, THIS WAS CLEANED TO CORRECT THE OBSERVATION. IT IS UNKNOWN IF THIS CONTRIBUTED TO THE REPORTED ISSUE. THE CUSTOMER WAS SHOWN HOW TO INSPECT AND CLEAN THE HP FILTER. IT WAS OBSERVED A GROUNDING COIL WAS NOT INSTALLED AND THE FSE INSTALLED ONE, IT IS UNDETERMINED IF THIS CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS SUBJECTED TO FULL FUNCTIONALITY TESTING WITH PASSING RESULTS. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM MADE CONTACT WITH THE TREATMENT PROVIDER AND FOUND THAT THE TREATMENT WAS PERFORMED ON (B)(6) 2026 FOR TELANGIECTASIA ON THE NOSE. DURING THE PROCEDURE, A LOUD POP WAS HEARD AND OBSERVED WITH A BRIGHT SPARK, THIS WAS FOLLOWED BY WHAT AP

  Patient problems: Insufficient Information

  MAUDE report 24575684 ↗
• MalfunctionMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING LASER VASCULAR TREATMENT WITH A CLARITY II DEVICE, A SPARK OCCURRED FOLLOWED BY VISIBLE BLACK "SOOT" ON THE SKIN.

  Patient problems: Insufficient Information

  MAUDE report 24567944 ↗
• InjuryMar 4, 2026Environmental Particulates

  IT WAS REPORTED THAT DURING VESSEL TREATMENT ON THE NOSE AND CHEEKS, A LOUD "POP" SOUND WAS HEARD FOLLOWED BY A SPARK AND A BLACK SOOT MARK WAS LEFT ON THE PATIENT. THE SOOT WAS WIPED AWAY AND WHEN THE PATIENT RETURNED FOR FOLLOW-UP TREATMENT APPROXIMATELY A MONTH LATER, THERE WAS A RED CIRCLE ON THE NOSE THAT STARTED TO SCAB.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24512809 ↗
• InjuryMar 4, 2026Off-Label Use

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POTENTIAL LASER BURN ON THE FACE FOLLOWING LASER VASCULAR TREATMENT ON THE FACE WITH A CLARITY II DEVICE. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER WENT TO THE TREATMENT PROVIDER SITE FOR A DEVICE EVALUATION. DURING THIS TIME, THE DEVICE WAS SUBJECTED TO MULTIPLE TESTS INCLUDING FULL FUNCTIONALITY TESTING WITH PASSING RESULTS. THE DEVICE WAS FOUND TO BE WORKING TO PUBLISHED SPECIFICATIONS. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM MADE CONTACT WITH THE TREATMENT PROVIDER AND DETERMINED THAT THE PATIENT WAS TREATED WITH AN OFF LABEL TREATMENT. VASCULAR LASER TREATMENTS ARE NOT CONSIDERED OFF LABEL IN CANADA WITH THE EXCEPTION OF PORT WINE STAIN INDICATIONS. TREATMENT PARAMETER DETAILS WERE REQUESTED, BUT THE TREATMENT PROVIDER DID NOT SUPPLY COMPLETE CLINICAL DETAILS INCLUDING TREATMENT PARAMETERS, PROTOCOL LAYERING, TECHNIQUE DETAILS, DEGREE OF OVERLAP AND USE OF ADDITIONAL POST COOLING REMAINS UNKNOWN. THE PATIENT UNDERWENT TWO TREATMENTS FOR TELANGIECTASIA AND ROSACEA ON BOTH CHEEKS. THE FIRST TREATMENT WAS ON (B)(6) 2025 AND WAS WELL TOLERATED WITH NO REPORTED SIDE EFFECTS. TREATMENT NUMBER TWO (#2) WAS PERFORMED ON (B)

  Patient problems: Scar Tissue

  MAUDE report 24512087 ↗
• MalfunctionMar 4, 2026Environmental Particulates

  IT WAS REPORTED THAT DURING VESSEL TREATMENT ON THE NOSE AND CHEEKS, A LOUD "POP" SOUND WAS HEARD FOLLOWED BY A SPARK AND A BLACK SOOT MARK WAS LEFT ON THE PATIENT. THE SOOT WAS WIPED AWAY AND WHEN THE PATIENT RETURNED FOR FOLLOW-UP TREATMENT APPROXIMATELY A MONTH LATER, THERE WAS A RED CIRCLE ON THE NOSE THAT STARTED TO SCAB. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER WENT TO THE TREATMENT PROVIDER SITE FOR A DEVICE EVALUATION. DURING THIS TIME, THE REPORTED ISSUE WAS UNABLE TO BE DUPLICATED. THE DEVICE WAS SUBJECTED TO MULTIPLE TESTS INCLUDING FULL FUNCTIONALITY TESTING, ENERGY TESTS AND FULL VISUAL INSPECTION WITH NO DISCREPANCIES OBSERVED. THE DEVICE WAS FOUND TO BE WORKING WITHIN PUBLISHED SPECIFICATIONS. IT IS UNDETERMINED WHAT CAUSED THE REPORTED INCIDENT. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM MADE CONTACT WITH THE TREATMENT PROVIDER AND DETERMINED THAT THE PROVIDER TREATED THE PATIENT WITH AN OFF LABEL INDICATION AT THEIR OWN DISCRETION. IT IS UNKNOWN IF THIS CONTRIBUTED TO THE REPORTED LOUD POP, SPARK AND BLACK MARK THAT WAS REPORTED TO BE LEFT ON THE PATIENT, OR THE RED MARK THAT REMAINED ON THE PATIENTS NOSE ONE MONTH POST TREATMENT. TO REDUCE THE PROBA

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24507900 ↗
• InjuryMar 4, 2026Off-Label Use

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POTENTIAL LASER BURN ON THE FACE FOLLOWING LASER VASCULAR TREATMENT ON THE FACE WITH A CLARITY II DEVICE.

  Patient problems: Scar Tissue

  MAUDE report 24506409 ↗
• MalfunctionFeb 27, 2026Environmental Particulates

  IT WAS REPORTED ON 1/21/2026 THAT DURING LEG VEIN TREATMENT WITH A CLARITY II DEVICE PERFORMED ON (B)(6) 2026, THE DEVICE MADE A LOUD POP SOUND, SPARKED AND LEFT A BLACK "SOOT" MARK ON THE PATIENTS FOOT THAT WOULD NOT WIPE AWAY, THERE WAS A BLISTER IN THE CENTER OF THAT SPOT. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT PROVIDER SITE FOR A DEVICE EVALUATION. DURING THIS TIME THE DEVICE WAS SUBJECTED TO ENERGY TESTING, SPOT SIZE TESTING, BEAM SAMPLE TESTING AND FULL FUNCTIONALITY TESTING WITH PASSING RESULTS. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION, THE DEVICE WAS FOUND TO BE WORKING TO PUBLISHED SPECIFICATIONS. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM MADE CONTACT WITH THE TREATMENT PROVIDER TO REVIEW THE TREATMENT PARAMETERS USED. IT WAS DETERMINED THAT THE TREATMENT PARAMETERS USED WERE WITHIN THE RECOMMENDED CLINICAL GUIDELINES OF THE QUICKSTART GUIDE (QSG), THE ICD SETTINGS BEING USED WERE 10/20/10 WHEN THE LOUD POP, SPARK AND SOOT LEFT OF THE PATIENT OCCURRED. THESE ICD SETTINGS HAVE RECENTLY BEEN UPDATED TO 10/10/10 IT IS POSSIBLE THAT THE TREATMENT SETTINGS CONTRIBUTED TO THE SPARK AND BURN, HOWEVER, IT CANNOT BE CONFIRMED. AD

  Patient problems: Burn(s)

  MAUDE report 24475677 ↗
• MalfunctionFeb 20, 2026Gas/Air Leak

  IT WAS REPORTED ON (B)(6) 2026 THAT DURING TRAINING ON (B)(6) 2026 CRYOGEN STARTED SPILLING FROM THE HANDPIECE RESULTING IN A RAISED RED PATCH ON THE LEG. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE FOR A DEVICE EVALUATION. DURING THIS TIME, THE REPORTED ISSUE WAS OBSERVED. THE NOZZLE INSIDE THE HANDPIECE WAS FOUND TO BE LOOSE AND WAS TIGHTENED TO CORRECT THE ISSUE. IT IS UNDETERMINED HOW THIS NOZZLE BECAME LOOSE. AFTER THE NOZZLE WAS TIGHTENED, THE DEVICE PRESSURE WAS TESTED WITH PASSING RESULTS. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL WAS ORIGINALLY TOLD BY THE TREATMENT SITE THAT THE PATIENT (WHO WAS REPORTED TO BE A STAFF MEMBER) "HAD A BLISTER ON THE TREATMENT AREA BUT IS FINE". ADDITIONAL CONTACT ATTEMPTS TO THE TREATMENT SITE WERE MADE TO OBTAIN INFORMATION ABOUT HOW THE PATIENT WAS HEALING AS WELL AS REQUESTING ADDITIONAL PHOTOS OF HEALING, HOWEVER, THESE INFORMATION REQUESTS WENT UNANSWERED. IMAGES OF THE BLISTER WERE NOT PROVIDED FOR EVALUATION. THE EVENT IS REPORTABLE PER FDA MEDICAL DEVICE REPORTING TITLE 21 CFR PART 803 SINCE A MALFUNCTIONED OCCURRED AND WOULD LIKELY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WE

  Patient problems: Burn(s)

  MAUDE report 24403338 ↗
• MalfunctionFeb 19, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING TRAINING ON (B)(6) 2026, CRYOGEN STARTED SPILLING FROM THE HANDPIECE RESULTING IN A RAISED RED PATCH ON THE LEG.

  Patient problems: Burn(s)

  MAUDE report 24389667 ↗
• MalfunctionFeb 19, 2026Environmental Particulates

  IT WAS REPORTED ON (B)(6) 2026 THAT DURING VESSEL TREATMENT WITH A CLARITY II DEVICE PERFORMED ON (B)(6) 2026, THE DEVICE SPARKED, LEFT A BLACK MARK ON THE PATIENTS CHIN THAT WAS WIPED AWAY AND BURN WHERE THE BLACK MARK WAS.

  Patient problems: Burn(s)

  MAUDE report 24389658 ↗
• MalfunctionJan 30, 2026Operating System Version or Upgrade Problem

  IT WAS REPORTED THAT THE CLARITY II SYSTEM WILL NOT STOP FIRING LASERING PULSE EVEN WHEN FINGER SWITCH IS NOT PRESSED. THE SITE ALSO REPORTED THAT THIS HAPPENED TWICE WHEN THEY WERE USING THE HANDPIECE AND THE FINGER SWITCH TO DISCHARGE THE LASER. THE OPERATOR DID MENTION THAT THEY DO NOT USE THE FOOT SWITCH TO DISCHARGE LASER PULSES AND THAT NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225708 ↗
• MalfunctionJan 30, 2026Operating System Version or Upgrade Problem

  IT WAS REPORTED THAT THE CLARITY II SYSTEM WILL NOT STOP FIRING LASERING PULSE EVEN WHEN FINGER SWITCH IS NOT PRESSED. THE SITE ALSO REPORTED THAT THIS HAPPENED TWICE WHEN THEY WERE USING THE HANDPIECE AND THE FINGER SWITCH TO DISCHARGE THE LASER. THE OPERATOR DID MENTION THAT THEY DO NOT USE THE FOOT SWITCH TO DISCHARGE LASER PULSES AND THAT NO INJURIES WERE REPORTED. CYNOSURE LUTRONIC CLINICAL DETERMINED THAT NO PATIENT OR PROVIDER INJURY HAD OCCURRED. A CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE PROVIDER SITE AND EVALUATED THE DEVICE. THE FSE WAS UNABLE TO DUPLICATE THE REPORTED INCIDENT OF UNINTENDED CONTINUOUS LASING WHEN USING THE HANDPIECE FINGER SWITCH, HOWEVER, THE FSE DID IDENTIFY MULTIPLE CONTRIBUTING FACTORS THAT MAY HAVE CAUSED THE REPORTED ISSUE. THE DEVICE HANDPIECE GROUNDING (FERRITE COIL AND INTERNAL GROUNDING CABLE) WERE NOT INSTALLED AND THE DEVICE GUI/SYSTEM/MFC FIRMWARE WERE OUTDATED. TO CORRECT THE ISSUE, THE FSE INSTALLED A FERRITE COIL, UPDATED ALL FIRMWARE TO THE LATEST REVISIONS. IT WAS RECOMMENDED THAT THE CUSTOMER REPLACE THE HANDPIECE. ADDITIONALLY, THE FSE OBSERVED A LOOSE SCREW FROM THE FINGER SWITCH BOARD THAT WAS NOT SEATED CORREC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225569 ↗
• MalfunctionJan 29, 2026Defective Component

  IT WAS REPORTED THAT A WHILE CONDUCTING TRAINING A CLARITY II DEVICE WAS CONTINUOUSLY SPRAYING CRYOGEN. THE PATIENT WAS REPORTEDLY BURNED BY THE CRYOGEN. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE FOR A DEVICE EVALUATION. DURING THIS TIME, THE FSE OBSERVED THE REPORTED ICD LEAK. TO CORRECT THE ISSUE THE FSE REPLACED THE HANDPIECE AND COMPLETED ALL REQUIRED VERIFICATIONS. THE REPORTED ICD LEAK ISSUE WAS CORRECTED. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM MADE MULTIPLE CONTACT ATTEMPTS TO INQUIRE ON HOW THE PATIENT WAS HEALING, HOWEVER, THERE WAS NO ADDITIONAL INFORMATION PROVIDED. SINCE A DEVICE MALFUNCTION OCCURRED, WE ARE REPORTING THIS EVENT.

  Patient problems: Cryogenic Burn

  MAUDE report 24215809 ↗
• MalfunctionJan 29, 2026Defective Component

  IT WAS REPORTED THAT A WHILE CONDUCTING TRAINING A CLARITY II DEVICE WAS CONTINUOUSLY SPRAYING CRYOGEN. THE PATIENT WAS REPORTEDLY BURNED BY THE CRYOGEN.

  Patient problems: Cryogenic Burn

  MAUDE report 24208953 ↗
• MalfunctionJan 21, 2026Operating System Version or Upgrade Problem

  IT WAS REPORTED THAT A CLARITY II DEVICE WAS FIRING WITHOUT THE BUTTON BEING PRESSED. THE DEVICE ALSO REPORTED NOT TO RECOGNIZE SPOT SIZES CORRECTLY, AND IS POWERING OFF AND ON. LASTLY, THE DEVICE WAS REPORTED TO DISPLAY "CHECK ICD" ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED IN THIS CASE. A TRAINED CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) WENT TO THE TREATMENT PROVIDER SITE FOR A DEVICE EVALUATION. DURING THIS TIME, THE FSE DID OBSERVE THE REPORTED FIRING WITHOUT THE BUTTON BEING PRESSED. TO CORRECT THIS ISSUE THE HANDPIECE WAS REPLACED AND THE FIRMWARE WAS UPGRADED (GUI 1.09 SYS 1.08 MFC 1.04, HP 1.05). IT WAS OBSERVED THAT THE ICD BEING UTILIZED IS THE NON-ECO 780G AND TO CORRECT THE ICD ISSUE THE FSE INSTALLED THE ECO ICD IN THE DEVICE. LASTLY, THE FSE RAN BURN SAMPLE TESTS WITH PASSING RESULTS, THERE WAS NO INDICATION OF SPOT SIZE ISSUES. THE DEVICE PASSED ALL FINAL TESTS AND MEETS PUBLISHED SPECIFICATIONS. A MEMBER OF THE CYNOSURE LUTRONIC CLINICAL TEAM CONFIRMED THAT THERE WAS NO PATIENT OR PROVIDER INJURY REPORTED DURING THIS INCIDENT. SINCE A REPORTED MALFUNCTION OCCURRED AND THERE IS POTENTIAL SERIOUS INJURY, WE ARE REPORTING THIS AS AN ARO EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136698 ↗