MAUDE Adverse Event Report: CYNOSURE LUTRONIC TECHNOLOGY CORPORATION CLARITY II

Catalog Number	1110200210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Cynosure lutronic became aware of a clarity ii sparking during treatment.Treatment clinic relayed seeing a spark and hearing it.This occurred with three patients during separate treatments using icd 10/10/10 settings.It was noted that the device is eco-friendly; however, the treatment clinic reported that they may have been using a cryogen canister with a red lid, which contains a non-environmentally friendly cryogen.A member of the cynosure lutronic (cl) clinical team contacted the treatment clinic on 26 may 2026 to further investigate the incident.On 2 june 2026, cl clinical became aware that patient experienced a burn.No additional information or images was provided although requested.Burns are an expected side effect from such treatments.On 23 june 2026 a trained cl field service engineer (fse) went to the site to perform a device evaluation.Fse performed a system evaluation and functional check.Handpiece and fiber were then inspected.Fse checked the energy on both alex and yag using 18mm.Fse also inspected and tested 3mm/5mm, 8mm/10mm/12mm cartridges on customer's reported fluence setting.Fse confirms no issues were found and laser energy was within specification.Root cause to how the device sparked is inconclusive since the device was found to be operating within specification and no other treatment information was made available.The event is reportable per fda medical device reporting title 21 cfr part 803 since an observed malfunction occurred and could likely cause or contribute to a serious injury if the malfunction were to recur.

• Brand Name: CLARITY II
• Common Device Name: CLARITY II
• Manufacturer (Section D): CYNOSURE LUTRONIC TECHNOLOGY CORPORATION; 55 samwon-ro; deogyang, goyang gyeonggi 10550 ; KS 10550
• MDR Report Key: 25623500
• Report Number: 1222993-2026-00059
• Device Sequence Number: 9011621
• Product Code: GEX
• UDI-Device Identifier: 08800291820040
• UDI-Public: (01)08800291820040(11)250418
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2026
• Report Date (Section F): 06/25/2026

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: Other
• Device Catalogue Number: 1110200210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/26/2026
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/25/2026