AviClearRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816722021700), received between Nov 29, 2025 and Nov 29, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE DEVICE OPERATOR USED THE 7-SPOT ARRAY TO TREAT THE SIDE OF THE NOSE (THE NASAL ALAR CREASE). THE AVICLEAR INSTRUCTIONS FOR USE CLEARLY STATE THAT THIS AREA SHOULD NOT BE TREATED. USING THE DEVICE IN THIS SPOT IS CONSIDERED USER ERROR. THE SHAPE OF THE NASAL CREASE MAKES IT HARD TO COOL THE SKIN PROPERLY BEFORE, DURING, AND AFTER THE LASER PULSE, WHICH INCREASES THE CHANCE OF A BURN IF THE AREA IS TREATED. THE PATIENT WHO RECEIVED THE AVICLEAR TREATMENT ALSO SUBMITTED A VOLUNTARY REPORT TO THE FDA (MW5177086), CHARACTERIZING THE INJURY AS A "THIRD-DEGREE BURN." THE TREATING CLINIC DESCRIBED THE INJURY AS A "SECOND-DEGREE BURN." BURNS AND SCARRING ARE IDENTIFIED IN THE AVICLEAR IFU AS KNOWN POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH THE PROCEDURE. NO CUTERA PERSONNEL WERE PRESENT DURING THE TREATMENT, AND CUTERA WAS NOT INVOLVED IN THE EVALUATION, CLINICAL MANAGEMENT, OR DECISION-MAKING REGARDING PATIENT CARE. ON (B)(6) 2025, THE CLINIC REPORTED THAT THE TREATMENT-RELATED BURN WAS "HEALING NICELY." AT THAT TIME, THE ONLY MEDICAL INTERVENTION PROVIDED WAS TOPICAL "SILVER SULFADIAZINE", WHICH IS STANDARD WOUND CARE FOR PARTIAL-THICKNESS BURNS. ON (B)(6) 2025, THE CLINIC AGAIN CONFIR

  Patient problems: Partial thickness (Second Degree) Burn; Scar Tissue

  MAUDE report 23675905 ↗