Clear & Brilliant CB-CONSOLERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850608002643), received between Mar 20, 2024 and Sep 10, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Firing Problem” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2024Unexpected Shutdown; Unexpected Shutdown

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED INTENSE ERYTHEMA AND DARKENING OF THE SKIN ON THEIR FACE FOLLOWING A CLEAR+BRILLIANT TREATMENT. THE PATIENT, A STAFF MEMBER AT THE CUSTOMER SITE, RECEIVED CLEAR+BRILLIANT TREATMENT TO THEIR FACE. 6 PASSES WERE PERFORMED AT THE HIGHEST TREATMENT LEVEL. IT WAS REPORTED THE CONSOLE POWERED OFF PRIOR TO THE END OF THE PROCEDURE. THIS WAS THE FIRST TIME THE TREATMENT TIP WAS USED ON A PATIENT. AT THE END OF TREATMENT, VIVIER DERMAV CREAM WAS APPLIED TO THE PATIENT¿S FACE. APPROXIMATELY A WEEK FOLLOWING THE PROCEDURE, THE PATIENT OBSERVED HYPERPIGMENTATION AND INTENSE ERYTHEMA IN THE TREATED AREAS. THE PATIENT WAS THEN PRESCRIBED FUCIDIN OINTMENT AND A HYDROVAL CREAM. THE PATIENT¿S CURRENT STATUS IS THERE IS A DARKENING OF THEIR SKIN. IT IS UNKNOWN IF THERE WILL BE ANY PERMANENT DAMAGE OR SCARRING. THE PATIENT HAD NOT UNDERGONE ANY OTHER PROCEDURE IN THE SAME SYMPTOM AREA ON THE PROCEDURE DAY OR WITHIN 90 DAYS PRIOR. A SOLTA MEDICAL REVIEWER EXAMINED PICTURES OF THE PATIENT. DARKENED SKIN AND POST INFLAMMATORY HYPERPIGMENTATION AREAS WERE VISIBLE ON THE PATIENT'S CHEEKS AND FOREHEAD. PICTURES WERE TAKEN A MONTH FOLLOWING THE PROCEDURE.

  Patient problems: Erythema; Hyperpigmentation

  MAUDE report 20186489 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED SWOLLEN FAT PADS UNDER HER LEFT EYE AND FACE WITH MORE TANNED SKIN, FOLLOWING A CLEAR+BRILLIANT TREATMENT. THIS WAS THE SECOND TREATMENT OF THREE TREATMENTS. SEE RELATED REPORTS FOR SUBSEQUENT TREATMENTS FOR THE SAME PATIENT. THE PATIENT DID NOT RECEIVE CLEAR+BRILLANT TREATMENT IN THE SAME SYMPTOM AREA WITHIN 90 DAYS. IT WAS REPORTED THEY RECEIVED BOTOX AND VIVA TREATMENTS SEVERAL TIMES IN THEIR PAST HISTORY. IT IS UNKNOWN WHEN THE SYMPTOMS WERE NOTICED ON THIS EVENT AND IT'S UNKNOWN IF THERE WAS ANY SECONDARY INTERVENTION GIVEN AT THE TIME. MULTIPLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. IN COMPARING SOME PICTURES DATED APPROXIMATELY TWO YEARS AND SIX MONTHS BEFORE THE PROCEDURE TO PICTURES DATED TWO MONTHS AFTER THIS TREATMENT, SHOW THAT THE PATIENT'S FACE IS ERYTHEMATOUS, BUT NO OTHER APPARENT DIFFERENCE IS VISIBLE AROUND EYES. MILD EDEMA IS VISIBLE AROUND EYES IN DIFFERENT ANGLES. HOWEVER, A PICTURE DATED ONE MONTH BEFORE THIS TREATMENT SHOWED MILD EDEMA AND SURFACE IRREGULARITY. THERE ARE OTHER PICTURES WITH NO DATE COMPARING PATIENT'S FACE. EDEMA IS VISIBLE UNDER THE EYE ON BOTH SIDES. THE TREATMENT LEVEL FOR THIS E

  Patient problems: Erythema; Skin Discoloration; Swelling/ Edema

  MAUDE report 19727370 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED SWOLLEN FAT PADS UNDER HER LEFT EYE AND FACE WITH MORE TANNED SKIN, FOLLOWING A CLEAR+BRILLIANT TREATMENT. THIS WAS THE FIRST TREATMENT OF THREE TREATMENTS. SEE RELATED REPORTS FOR SUBSEQUENT TREATMENTS FOR THE SAME PATIENT. IT IS UNKNOWN IF THE PATIENT RECEIVED CLEAR+BRILLANT TREATMENT IN THE SAME SYMPTOM AREA WITHIN 90 DAYS. IT WAS REPORTED THEY RECEIVED BOTOX AND VIVA TREATMENTS SEVERAL TIMES IN THEIR PAST HISTORY. IT IS UNKNOWN WHEN THE SYMPTOMS WERE NOTICED ON THIS EVENT AND IT'S UNKNOWN IF THERE WAS ANY SECONDARY INTERVENTION GIVEN AT THE TIME. MULTIPLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER. IN COMPARING SOME PICTURES DATED A YEAR BEFORE THE PROCEDURE TO PICTURES DATED 8 MONTHS POST TREATMENT TO THE DAY OF TREATMENT SHOW THAT THE PATIENT'S FACE IS ERYTHEMATOUS, BUT NO OTHER APPARENT DIFFERENCE IS VISIBLE AROUND EYES. MILD EDEMA IS VISIBLE AROUND EYES IN DIFFERENT ANGLES. HOWEVER, MORE EDEMA IS VISIBLE IN A PICTURE 5 MONTHS POST TREATMENT. ONE PICTURE ON 5 MONTHS POST TREATMENT SHOW MILD EDEMA AND SURFACE IRREGULARITY VISIBLE COMPARING TO DATE OF TREATMENT. THERE ARE OTHER PICTURES WITH NO DATE COMPARING PATIENT'S FA

  Patient problems: Erythema; Skin Discoloration; Swelling/ Edema

  MAUDE report 19727366 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED SWOLLEN FAT PADS UNDER HER LEFT EYE AND FACE WITH MORE TANNED SKIN, A FEW DAYS FOLLOWING HER LAST CLEAR+BRILLIANT TREATMENT. THIS WAS THE LATEST TREATMENT OF THREE TREATMENTS. SEE RELATED REPORTS FOR PREVIOUS TREATMENTS FOR THE SAME PATIENT. THE PATIENT DID RECEIVE CLEAR+BRILLIANT TREATMENT IN THE SAME SYMPTOM AREA WITHIN 90 DAYS. THEY ALSO HAVE RECEIVED BOTOX AND VIVA TREATMENTS SEVERAL TIMES IN THEIR PAST HISTORY. THE PATIENT HAD RECEIVED PREVIOUS CLEAR+BRILLIANT TREATMENTS AND REPORTED AFTER THEIR LATEST TREATMENT THAT AFTER EACH PROCEDURE IT APPEARED THE AREA UNDER THEIR EYES, ESPECIALLY THE MALAR FAT PAD, DETERIORATES. THE TREATING PHYSICIAN EXAMINED THE PATIENT AND OBSERVED A LITTLE RESIDUAL INFLAMMATION. THE PATIENT WAS THEN PRESCRIBED PREDNISONE X5 DAYS, AND ADVISED TO USE A COLD COMPRESS, IF NEEDED, 5-10 MINUTES A DAY. THE PATIENT¿S CURRENT STATUS IS THEY ARE ANXIOUS AND CONCERNED ABOUT THE AREA UNDER THEIR EYES IMPROVING. THE PATIENT¿S OUTCOME IS UNKNOWN. A SOLTA MEDICAL REVIEWER EXAMINED IMAGES OF THE PATIENT FROM THEIR PREVIOUS TREATMENTS AND COMPARED TO THEIR LATEST TREATMENT. THERE WAS NO DIFFERENCE FROM THE AMOUNT O

  Patient problems: Anxiety; Erythema; Skin Discoloration; Swelling/ Edema

  MAUDE report 19727362 ↗
• InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED THAT A PATIENT EXPERIENCED BLISTERS AND PINPOINT BLEEDING ON THE CHEEK ON THE EVENING FOLLOWING A CLEAR + BRILLIANT TREATMENT TO THE FACE. THE PATIENT WAS TREATED WITH AN UNKNOWN NUMBING CREAM. THE CURRENT STATUS AT THE TIME WAS REPORTED AS SCABBING. BASED UPON AN EVALUATION OF AVAILABLE PICTURES BY THE MEDICAL REVIEWER, THE FIRST PICTURE SHOWED ERYTHEMA AND INFLAMMATION ALL OVER THE FACE. ADDITIONAL PICTURES SHOWED PINPOINT BLEEDING AND SCABBING FORMATION ON ONE SIDE OF THE CHEEK. IT WAS REPORTED THAT THE PATIENT STOPPED RETINOL AND AHA/BHA PRODUCTS 3 WEEKS BEFORE THE TREATMENT. IT WAS ALSO CONFIRMED THAT THE PATIENT WAS NOT ON BLOOD THINNERS NOR DID DO THEY HAVE A DIAGNOSIS OF ANY AUTOIMMUNE SYSTEM DISORDERS. HOWEVER, THE PATIENT REPORTED TO THE USER FACILITY THAT SHE BURNS EASILY. THE USER FACILITY REPORTED THAT NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE BEING PERFORMED IN THE SAME AREA WHERE SYMPTOMS OCCURRED. THE PATIENT HAS UNDERGONE EXCEL V TREATMENT/ HALF FACE APPROXIMATELY 5 AND 6 MONTHS AGO. THE INCIDENT OCCURRED WITH 3 PASSES AT THE HIGHEST ENERGY OF 2 KJ. NO OTHER SYSTEM ERRORS OCCURRED OR WERE NOTICED DURING THE TREATMENT. THIS TREATME

  Patient problems: Blister; Erythema; Skin Inflammation/ Irritation

  MAUDE report 19494263 ↗
• InjuryJun 5, 2024Firing Problem; Firing Problem

  A USER FACILITY REPORTED A POSSIBLE BURN TO THE PATIENT'S CHEEK 27 DAYS POST CLEAR AND BRILLIANT FACIAL TREATMENT. IT HAD BEEN REPORTED THAT THE PATIENT'S CURRENT STATUS AT THE TIME WAS ¿DARK SKIN WITH PINK AROUND IT.¿ AVAILABLE PICTURES WERE REVIEWED BY THE MEDICAL REVIEWER AND ERYTHEMA, INFLAMMATION, AND DARK SKIN WERE VISIBLE DUE TO A POSSIBLE BURN ON BOTH SIDES OF THE CHEEKS. THE PROVIDER NOTED THAT PATIENT HAD NO FURTHER COMPLICATIONS AND PROVIDED AN UNSPECIFIED MEDICATION TO HELP WITH THE PIGMENTATION CONDITION. THE PHYSICIAN DOES NOT BELIEVE THAT THERE WILL BE ANY PERMANENT DAMAGE OR SCARRING. NO OTHER TREATMENTS (BESIDES THE ONE REPORTED) WERE PERFORMED IN THE SAME AREA. THE PATIENT HAS HAD A PERMEA TREATMENT ON THE AFFECTED AREA APPROXIMATELY 7 MONTHS AGO. THE HIGHEST ENERGY LEVEL USED AT THE TIME OF THE TREATMENT IS UNKNOWN. THE SYSTEM DISPLAYED A PERSISTENT ¿REMOVE TIP¿ MESSAGE DURING THE TREATMENT, BUT IT WAS CLEARED WITH ASSISTANCE FROM PRODUCT SUPPORT. THE SAME INDIVIDUAL TIP THAT WAS USED DURING THIS TREATMENT HAS NOT BEEN USED ON OTHER PATIENTS; THE USER FACILITY DISCARDS THE TIP AFTER EACH TREATMENT. A BURN PAPER TEST WAS PERFORMED PRIOR TO USING THE DEVICE AND IT

  Patient problems: Burn(s); Erythema; Inflammation; Skin Discoloration

  MAUDE report 19473803 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY REPORTED A BURN TO THE PATIENT'S HAND DURING A CLEAR AND BRILLIANT PROCEDURE. THERE IS NO OTHER INFORMATION AVAILABLE AT THIS TIME. A REQUEST FOR FURTHER INFORMATION HAS BEEN SENT.

  Patient problems: Burn(s)

  MAUDE report 18943294 ↗