MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Medical Device Problem Code	Environmental Particulates (2930)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on 1/21/2026 that during leg vein treatment with a clarity ii device performed on (b)(6) 2026, the device made a loud pop sound, sparked and left a black "soot" mark on the patients foot that would not wipe away, there was a blister in the center of that spot.A trained cynosure lutronic field service engineer (fse) went to the treatment provider site for a device evaluation.During this time the device was subjected to energy testing, spot size testing, beam sample testing and full functionality testing with passing results.There was no indication of a device malfunction, the device was found to be working to published specifications.A member of the cynosure lutronic clinical team made contact with the treatment provider to review the treatment parameters used.It was determined that the treatment parameters used were within the recommended clinical guidelines of the quickstart guide (qsg), the icd settings being used were 10/20/10 when the loud pop, spark and soot left of the patient occurred.These icd settings have recently been updated to 10/10/10 it is possible that the treatment settings contributed to the spark and burn, however, it cannot be confirmed.Additionally, the provider used a makeup wipe to cleanse the area prior to treatment.It is recommended that an alcohol wipe be used to cleanse the treatment area.Cryogen is applied to the treatment site during vascular treatment to precool the skin.The cryogen begins to vaporize from the surface of the skin shortly after contact.The laser fires onto the surface of the skin after a delay time.The spark/ignition events occur when residual cryogen vapors remaining on the skin surface interact with the high-energy 1064 nm laser fluence.Longer pre-cooling and delay times increase the likelihood of uneven vapor accumulation, thereby elevating the risk of ignition.This can be observed as a spark and can result in topical burn.To reduce the probability of reoccurrence, the clinical team discussed the importance of pre treatment preparation and using alcohol to properly cleanse treatment areas prior to treatment.The treatment site also acknowledged the safety notice letter that was recently sent out regarding the potential issue with the cryogen parameters recommended for vascular lesions.The treatment provider stated that they will adopt the recommended settings for the future.

• 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: 24475677
• Report Number: 1222993-2026-00011
• Device Sequence Number: 21236371
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: (01)08809447653723(11)240813
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2026
• Report Date (Section F): 02/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/29/2026
• Event Location: Outpatient Treatment Facility
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/27/2026