UltraClear AS-WB-00055Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850039149429), received between Jun 18, 2025 and Sep 25, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Use of Device Problem

  Initially reported via the ESG unified submission portal on 09/02/2026. Incorrect file type submitted with the initial report. This is a resubmission with the correct file type. On (b)(6)2026 the patient reached out directly to Acclaro's clinical team. This was forwarded to Acclaro QA for investigation. The patient reported fat loss under the eye as the result of UltraClear treatment. The patient reported receiving two treatments 2 days apart. The fat loss reported was noted after the second treatment. The treatments were performed on (b)(6)2026. On (b)(6)2026 the patient escalated their complaint to the clinic. The patient sought the opinion of a second dermatologist. The second dermatologist confirmed the fat loss. On 08/27/2026 Acclaro QA received the following documents:Completed Global Impact Form Email Communication between the clinic and patientPatient Treatment Consent FormsPhotographs of the patient throughout treatment and healing processOn 09/01/2026 Acclaro QA received a letter from the second dermatologist confirming the Fat loss in the under eye and treatment with tear trough fillers. Reportability assessment was performed on 09/02/2026.

  Patient problems: Atrophy

  MAUDE report 50897738 ↗
• InjurySep 23, 2026Use of Device Problem

  Patient problems: Hyperpigmentation; Localized Skin Lesion; Scar Tissue

  MAUDE report 50873248 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50161813 ↗
• InjuryJun 12, 2026Patient Device Interaction Problem

  ON (B)(6) 2026 THE PATIENT WAS TREATED WITH THE ULTRACLEAR DEVICE USING CLEAR GLIDE MODE ON THE FOREARMS. CLEAR GLIDE MODE DELIVERS LASER ENERGY IN A RANDOMIZED PATTERN OF RINGS. THE SETTINGS USED WERE 25% COVERAGE AND 20UM DEPTH. SHE EXPERIENCED REDNESS, INFLAMMATION, AND IRRITATION IN THE PATTERN OF THE TREATMENT. PHOTOGRAPHIC EVIDENCE PROVIDED CLEARLY SHOWED THE TREATMENT PATTERN IN THE IRRITATION ON THE FOREARMS. THE IRRITATION PERSISTED ON THE INNER PART OF THE FOREARMS LONGER THAN OTHER AREAS. THE TREATING PHYSICIAN PERFORMED FOLLOW UP TREATMENTS TO MITIGATE THE IRRITATION. SHE WAS TREATED WITH GLACIAL GLIDE, A DERMAL COOLING DEVICE, LIDEX CREAM (0.05% FLOUCINONIDE), AND V-BEAM, A 595NM LASER. THE TREATMENTS WERE EFFECTIVE AND THE IRRITATION FADED BUT WAS STILL VISIBLE ON (B)(6) 2026. THE PATIENT WAS NOT ON ANY PHOTOSENSITIZING TREATMENTS AND HAD RECEIVED ERBIUM LASER TREATMENT ON THE FACE BEFORE WITH NO ISSUES. THE PATIENT DEFINES HERSELF AS HAVING SENSITIVE SKIN ACCORDING TO THE TREATING PHYSICIAN. ACCLARO CLINICAL REVIEWED THE PROVIDED INFORMATION AND PHOTOGRAPHS. IN THE IMAGES DATED (B)(6) 2026 AND (B)(6) 2026, DIFFUSE PINPOINT RED-BROWN MACULES WERE OBSERVED INVOLVING TH

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25484839 ↗
• InjuryApr 20, 2026Use of Incorrect Control/Treatment Settings

  THE PATIENT REACHED OUT DIRECTLY TO ACCLARO TO REPORT THIS COMPLAINT ON (B)(6) 2026 IN REGARD TO A TREATMENT THAT OCCURED ON (B)(6) 2025. THE PATIENT REPORTED TRACKMARKS ON THE NECK AFTER A LASER CORING TREATMENT AND PERSISTENT ERYTHEMA. LASER CORING DELIVERS LASER ENERGY TO A SMALL REGION AT HIGH DEPTHS OF 0.5MM TO 4MM. ACCLARO CLINICAL REACHED OUT TO THE TREATING PHYSICIAN TO DISCUSS THE ISSUE. THE TREATING PHYSICIAN REPORTED USING LASER CORING MODE AT 2% COVERAGE AND 2MM DRILL DEPTH. 2MM DEPTH IS VERY AGGRESSIVE TREATMENT AND HAS BEEN KNOWN TO CAUSE TRACKMARKS (ALSO KNOWN AS STAMPING, PIXELATED STAMPING, OR GRIDMARKS) AND DELAYED HEALING IN SOME CASES WHEN USED ON AN INAPPROPRIATE PATIENT AND/OR ANATOMICAL REGION. THE TRACKMARKS PRESENT IN THE PHOTOGRAPHS PROVIDED FOR THIS CASE ARE ATYPICAL. IN MOST CASES THEY APPEAR AS PINPOINT INDENTATIONS IN A GRID PATTERN. IN THIS CASE THEY APPEAR AS RAISED HYPOPIGMENTED DOTS. THE TYPICAL TRACKMARKS ARE KNOWN TO HEAL WITH TIME, THOUGH IT MAY BE A MATTER OF MONTHS. IN ONE OTHER REPORTED CASE WE HAVE SEEN TRACKMARKS PRESENT IN THIS WAY, INTERNAL RECORD NUMBER CMP-000065. IN THAT CASE THE TREATMENT WAS PERFORMED IN A SIMILAR REGION (NECK) AND

  Patient problems: Hypopigmentation; Scar Tissue

  MAUDE report 24924660 ↗
• InjuryMar 6, 2026Use of Incorrect Control/Treatment Settings

  PATIENT WAS TREATED WITH LASER CORING AT 5% COVERAGE AND 1.5MM DRILL DEPTH IN THE SUBMENTAL REGION, AND 5% COVERAGE AND 1MM DRILL DEPTH IN THE LOWER FACE. A SECOND TREATMENT PASS OVER BOTH TREATMENT AREAS OF CLEAR MODE AT 35% COVERAGE AND 30UM RING DEPTH. PHOTOGRAPHS SHOW LAXITY IN THE SUBMENTAL REGION 4 WEEKS POST TREATMENT. FURTHER PHOTOGRAPHS SHOW THAT THE LAXITY HAS NOT REDUCED 4 MONTHS POST TREATMENT. ACCLARO CLINICAL REACHED OUT TO AN ACCLARO KEY OPINION LEADER (KOL) FOR HIS CLINICAL OPINION OF THE CASE. THE KOL CONTACTED IS A DERMATOLOGIST WITH SIGNIFCANT EXPERIENCE USING LASER DEVICES AND SPECIFICALLY USING THE ULTRACLEAR DEVICE. THE KOL STATED IN EMAIL THAT HE SUSPECTED WITH TREATMENT DEPTHS THIS DEEP ON THE SUBMENTAL REGION OF A THIN PATIENT IT IS LIKELY THAT ENERGY WAS DELIVERED TO THE HYPODERMIS RESULTING IN FAT INJURY AND VOLUME LOSS. HE SUSPECTED THAT THE LAXITY WOULD IMPROVE OVER TIME BUT WAS UNLIKELY TO RESOLVE COMPLETELY ON ITS OWN. HE SUGGESTED A COMBINATION OF TREATMENTS TO REMEDY THE LAXITY INCLUDING FURTHER ULTRACLEAR TREATMENT AT A SUPERFICIAL LEVEL FOCUSING ON SKIN TIGHTENING IN COMBINATION WITH BIOSTIMULATORY VOLUME RESTORATION. ACCLARO CLINICAL MET WITH THE

  Patient problems: Atrophy; Deformity/ Disfigurement

  MAUDE report 24533796 ↗
• InjuryJun 18, 2025No Apparent Adverse Event; No Apparent Adverse Event

  ON THE SEVENTH DAY AFTER TREATMENT, THE PATIENT REPORTED SKIN LESIONS. FOLLOWING A MEDICAL EXAMINATION, A VIRAL INFECTION IS SUSPECTED. PATIENT WAS PRESCRIBED CEFIXORAL AND DIFLUCAN TO PREVENT INFECTION.

  Patient problems: Localized Skin Lesion; Skin Infection

  MAUDE report 22286658 ↗