MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient's tattoo was accidentally hit during laser hair reduction treatment using clarity ii.Cynosure's medical director was consulted on this event and stated, "this is a third degree.I would expect a scar and the wound heals in by secondary intention.Once fully closed, i would recommend silicon gel, massage and either micro needling or non ablative laser resurfacing." patient was given topical antibiotics as preventative medication.Cynosure clinical determined the event was due to user error.During laser hair removal treatments the tattoo area must be strictly avoided.The clarity ii qsg instructs: "do not treat over or close to tattoos or permanent make up." due to scarring expected, this is considered a permanent injury and therefore reportable.

• Brand Name: CLARITY II
• Common Device Name: CLARITY II
• Manufacturer (Section D): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• MDR Report Key: 22060447
• Report Number: 1222993-2025-00011
• Device Sequence Number: 20657944
• Product Code: GEX
• UDI-Device Identifier: 08809447652542
• UDI-Public: 08809447652542
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025
• Report Date (Section F): 05/21/2025

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/21/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 05/21/2025