MAUDE Adverse Event Report: CUTERA, INC. AVICLEAR; POWERED LASER SURGICAL INSTRUMENT

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Scar Tissue (2060); Partial thickness (Second Degree) Burn (2694)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Mw5177086 was submitted by the patient who received the aviclear treatment.
Event or Problem Description
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.

• Brand Name: AVICLEAR
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): CUTERA, INC.; 3240 bayshore blvd.; brisbane CA 94005
• Manufacturer (Section G): CUTERA, INC.; 3240 bayshore blvd.; brisbane CA 94005
• Manufacturer Contact: julia brown ; 3240 bayshore blvd.; brisbane, CA 94005 ; 4156575500
• MDR Report Key: 23675905
• Report Number: 2954354-2025-00008
• Device Sequence Number: 15881847
• Product Code: GEX
• UDI-Device Identifier: 00816722021700
• UDI-Public: 010081672202170011220503
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K251149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 05/03/2022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 11/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian