MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Catalog Number	1110200210
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a potential laser burn on the face following laser vascular treatment on the face with a clarity ii device.A trained cynosure lutronic field service engineer went to the treatment provider site for a device evaluation.During this time, the device was subjected to multiple tests including full functionality testing with passing results.The device was found to be working to published specifications.A member of the cynosure lutronic clinical team made contact with the treatment provider and determined that the patient was treated with an off label treatment.Vascular laser treatments are not considered off label in canada with the exception of port wine stain indications.Treatment parameter details were requested, but the treatment provider did not supply complete clinical details including treatment parameters, protocol layering, technique details, degree of overlap and use of additional post cooling remains unknown.The patient underwent two treatments for telangiectasia and rosacea on both cheeks.The first treatment was on (b)(6) 2025 and was well tolerated with no reported side effects.Treatment number two (#2) was performed on (b)(6) 2026 and the patient reported side effects immediately after the procedure.The reported side effects are consisted with user error in the context of off label treatment.The cynosure lutronic medical director reviewed the supplied images and mentioned appearance of hypertrophic scar response as well as persistent erythema.It was advised that the patient be referred to a dermatologist or plastic surgeon due to the risk of permanent scarring.It was recommended that the patient consider massage, topical silicone gel treatment and micro needling.The medical director's recommendations were communicated with the treatment provider.The event is reportable per fda medical device reporting title 21 cfr part 803 since a serious injury occurred.

• 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: 24512087
• Report Number: 1222993-2026-00012
• Device Sequence Number: 10456722
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: (01)08809447653723(11)241218
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2026
• Report Date (Section F): 03/04/2026

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: Health Professional
• Device Catalogue Number: 1110200210
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/02/2026
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• 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: 03/04/2026