BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVICLEAR

    MDR report key: 23675905 · Received November 29, 2025

    Report

    Report Number
    2954354-2025-00008
    Event Type
    Injury
    Date Received
    November 29, 2025
    Date of Event
    September 19, 2025
    Report Date
    November 28, 2025
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    UDI-DI
    00816722021700
    PMA / PMN Number
    K251149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MW5177086 WAS SUBMITTED BY THE PATIENT WHO RECEIVED THE AVICLEAR TREATMENT.

    Description of Event or Problem · 0

    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 CONFIRMED THAT THE AREA WAS "HEALING" AND NOTED THAT THE "CLIENT IS HAPPY." BASED ON THE INFORMATION AVAILABLE AT THAT TIME, SPECIFICALLY, THE DOCUMENTED HEALING PROGRESSION AND ABSENCE OF ADDITIONAL MEDICAL INTERVENTION, THE EVENT DID NOT MEET THE CRITERIA FOR MANDATORY FDA REPORTING. ON (B)(6) 2025, DURING ROUTINE FOLLOW-UP REQUESTS FOR CONFIRMATION OF THE FINAL OUTCOME, THE CLINIC REPORTED THAT THEY WERE PROVIDING "SCAR REVISION TREATMENT". THE CLINIC DID NOT SPECIFY THE TYPE OF "SCAR REVISION" PROCEDURE PERFORMED AND DID NOT RESPOND TO SUBSEQUENT REQUESTS FOR CLARIFICATION. THE NEWLY DISCLOSED INFORMATION INDICATED THAT A SECONDARY MEDICAL INTERVENTION HAD BEEN PERFORMED TO PREVENT THE DEVELOPMENT OF PERMANENT DAMAGE, SPECIFICALLY THE FORMATION OF A VISIBLE SCAR IN A COSMETICALLY SENSITIVE AREA ON THE SIDE OF THE NOSE. BASED ON THIS UPDATED INFORMATION, THE INCIDENT WAS RE-EVALUATED AND DETERMINED TO MEET THE CRITERIA FOR MANDATORY DEVICE REPORTING. THE CASE IS THEREFORE BEING SUBMITTED TO THE FDA IN ACCORDANCE WITH APPLICABLE REGULATORY REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2400338 AVICLEAR POWERED LASER SURGICAL INSTRUMENT GEX CUTERA, INC. 00816722021700

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention