Clear & Brilliant CB-CONSOLE-RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850608002667), received between Dec 23, 2025 and Dec 23, 2025 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED UNDERGOING CLEAR & BRILLIANT TREATMENT DURING AN ELEVEN-MONTH COURSE OF NON-ABLATIVE LATER TREATMENTS (INCLUDING FRAXEL AND LASER GENESIS) INTENDED FOR TREATMENT OF ABDOMINAL, BUTTOCK, THIGH, AND KNEE STRIAE DURING WHICH RAPID AGING, VOLUME LOSS, AND HYPERPIGMENTATION WERE OBSERVED. THE PATIENT REPORTEDLY EXPERIENCED ANETODERMA (COMPLETE LOSS OF ELASTIN) AND FIBROSIS (BIOPSY-CONFIRMED). CLEAR AND BRILLIANT WAS THE ONLY TREATMENT APPLIED TO THE FACE, WHICH ALSO DEMONSTRATED ADVERSE EFFECTS. THE PATIENT LATER SOUGHT INDEPENDENT MEDICAL EVALUATION DUE TO PROGRESSION OF SYMPTOMS. A DERMATOLOGIST IDENTIFIED SIGNIFICANT STRUCTURAL SKIN COMPROMISE, PARTICULARLY IN THE ABDOMEN. A BIOPSY WAS PERFORMED, AND PATHOLOGY FINDINGS INDICATED NEAR-COMPLETE LOSS OF ELASTIN CONSISTENT WITH ANETODERMA. ADDITIONAL BIOPSIES REPORTEDLY DEMONSTRATED FIBROSIS AND MEASURABLE SUBCUTANEOUS FAT LOSS ACROSS ALL TREATED REGIONS. THE CLINIC THAT PERFORMED THE TREATMENT REPORTED THAT THERE IS NO EVENT INFORMATION AVAILABLE. THE PRACTITIONER WHO PERFORMED THE TREATMENT IS NO LONGER WITH THE PRACTICE AND THE OWNER OF THE CLINIC HAS BEEN OUT ON MEDICAL LEAVE FOR AN EXTENDED PERIOD AND IS NOT RETU

  Patient problems: Hyperpigmentation; Physical Asymmetry; Skin Inflammation/ Irritation; Tissue Breakdown

  MAUDE report 23885364 ↗