CLARITY II COMPL_BODY_ICDRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08809447652542), received between Sep 23, 2022 and Aug 8, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SITE PERFORMED A VESSEL/ROSACEA TREATMENT ON A PATIENT'S NOSE USING CLARITY II. DURING TREATMENT, A LOUD "POP" SOUND WAS HEARD, AND THEN A WHITE BLISTER APPEARED ON PATIENT'S NOSE. SITE STATES, "PATIENT RECEIVED A FULL THICKNESS BURN TO NOSE." CYNOSURE LUTRONIC FIELD SERVICE ENGINEER (FSE) ARRIVED ON SITE TO PERFORM DEVICE EVALUATION. DURING THIS TIME CYNOSURE LUTRONIC FSE CONFIRMED DEVICE HAD "ERROR 63 FAULTY POWER MODULE." CYNOSURE LUTRONIC FSE WAS UNABLE TO COMPLETE REPAIR DURING THIS VISIT. ON THE SECOND FSE VISIT, THE DEVICE WAS BROUGHT BACK TO THE CYNOSURE LUTRONIC (B)(6) LOCATION FOR FURTHER REPAIR. THE DEVICE HAD THE PUMPING BOARD ASSEMBLY REPLACED AND THE ERROR CODE WAS SUCCESSFULLY CLEARED. THE DEVICE WAS SUBJECTED TO FINAL TESTING AT THE WESTFORD LOCATION WITH PASSING RESULTS. IT IS UNKNOWN IF THE ERROR CODE OBSERVED CONTRIBUTED TO THE REPORTED EVENT. CYNOSURE LUTRONIC CLINICAL REACHED OUT TO THE SITE TO COLLECT ADDITIONAL INFORMATION. CYNOSURE LUTRONIC CLINICAL DETERMINED THE EVENT TO BE INCONCLUSIVE. REVIEW OF THE TREATMENT PARAMETERS USED WERE FOUND TO BE WITHIN THE RECOMMENDED SETTINGS WITHIN THE QUICK START GUIDE (QSG). THE PATIENT WAS PRESCRIBE

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 22750107 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SITE PERFORMED A VESSEL/ROSACEA TREATMENT ON A PATIENT'S NOSE USING CLARITY II. DURING TREATMENT, A LOUD "POP" SOUND WAS HEARD, AND THEN A WHITE BLISTER APPEARED ON PATIENT'S NOSE. SITE STATES, "PATIENT RECEIVED A FULL THICKNESS BURN TO NOSE."

  Patient problems: Blister

  MAUDE report 22738588 ↗
• MalfunctionJun 12, 2025Continuous Firing; Continuous Firing

  DURING A PREVENTATIVE MAINTENANCE VISIT ONSITE, CYNOSURE FIELD SERVICE ENGINEER OBSERVED CONTINUOUS FIRING WITH CLARITY II. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195251 ↗
• InjuryMay 21, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  PATIENT'S TATTOO WAS ACCIDENTALLY HIT DURING LASER HAIR REDUCTION TREATMENT USING CLARITY II. CYNOSURE'S MEDICAL DIRECTOR WAS CONSULTED ON THIS EVENT AND STATED, "THIS IS A THIRD DEGREE. I WOULD EXPECT A SCAR AND THE WOUND HEALS IN BY SECONDARY INTENTION. ONCE FULLY CLOSED, I WOULD RECOMMEND SILICON GEL, MASSAGE AND EITHER MICRO NEEDLING OR NON ABLATIVE LASER RESURFACING." PATIENT WAS GIVEN TOPICAL ANTIBIOTICS AS PREVENTATIVE MEDICATION. CYNOSURE CLINICAL DETERMINED THE EVENT WAS DUE TO USER ERROR. DURING LASER HAIR REMOVAL TREATMENTS THE TATTOO AREA MUST BE STRICTLY AVOIDED. THE CLARITY II QSG INSTRUCTS: "DO NOT TREAT OVER OR CLOSE TO TATTOOS OR PERMANENT MAKE UP." DUE TO SCARRING EXPECTED, THIS IS CONSIDERED A PERMANENT INJURY AND THEREFORE REPORTABLE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 22060447 ↗
• InjuryMay 20, 2025Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  A PATIENTS TATTOO WAS ACCIDENTLY HIT DURING LASER HAIR REDUCTION TREATMENT WITH CLARITY II DEVICE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 22054763 ↗
• MalfunctionSep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS BEING TREATED FOR LASER HAIR REMOVAL ON HER CHIN WITH 1064NM NDYAG LASER. WHILE LASER WAS FIRING, CRYOGEN FUNCTION STOPPED FIRING. THIS RESULTED IN MINOR 1ST DEGREE THERMAL BURN AND WAS TREATED WITH SILVADENE CREAM..

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 15472808 ↗