MAUDE Adverse Event Report: CYNOSURE LUTRONIC TECHNOLOGY CORPORATION CLARITY II

Catalog Number	1110200230
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient experienced a burn on the right nostril following a laser vascular treatment using clarity ii.Cynosure lutronic technology (clt) clinical team contacted the site to investigate the event.Clt clinical determined the event to be user error.Photos of the patient's injury was also provided.The treatment settings used were outside the recommended range.For the 1064 nm wavelength with the 5 mm handpiece, the recommended pulse duration is 50-30 ms.Per clt clinical, "the pulse duration used during this treatment was 15 ms, which likely contributed significantly to the reported side effects." the recommended fluence for the 1064 nm, 5 mm handpiece is 90-120 j/cm², whereas the fluence used was 140 j/cm², considerably exceeding the maximum recommended value.No patch test was performed prior to treatment, despite patch testing being highly recommended before proceeding.In addition, 25 pulses were delivered to the nostril area using the 5 mm handpiece.Considering the small treatment surface and the recommendation to avoid pulse overlap, the high number of pulses suggests that significant overlap or double pulsing may have occurred, further contributing to the reported side effects.Clt medical director (md) was consulted and relayed that the reported side effects were the result of user error.The combination of a short pulse duration, excessive fluence, and treatment technique likely contributed to the adverse outcome.The appropriate treatment technique and clinical settings were communicated to the treatment provider.Clt md recommends reeducation and retraining on device and proper patient selection.Clt md states that there might be a full thickness burn, but with the debris present they were unable to determine if it is a full thickness burn.Clt clinical then followed up for an update on the patient's healing.Clt md was consulted again with the updates provided.Clt md feels that it is still challenging to say but is leaning towards thinking burn was full thickness in the center at least.A full thickness burn is considered a third degree burn and a serious injury that may develop scarring and involve medical intervention.A device evaluation was not performed since site was not responding to the multiple requests made by service.If further information is received at a later date, a follow up report will be submitted.The event is reportable per fda medical device reporting title 21 cfr part 803 since patient experienced a serious injury.

• Brand Name: CLARITY II
• Common Device Name: CLARITY II
• Manufacturer (Section D): CYNOSURE LUTRONIC TECHNOLOGY CORPORATION; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• MDR Report Key: 25503868
• Report Number: 1222993-2026-00053
• Device Sequence Number: 10520138
• Product Code: GEX
• UDI-Device Identifier: 08800291820040
• UDI-Public: (01)08800291820040(11)211007
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Type of Report: Initial
• Report Date (Section B): 06/15/2026
• Report Date (Section F): 06/15/2026

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: Other
• Device Catalogue Number: 1110200230
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/19/2026
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2026
• 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 Age: 53 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/15/2026