MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Catalog Number	1110200230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that site performed a vessel/rosacea treatment on a patient's nose using clarity ii.During treatment, a loud "pop" sound was heard, and then a white blister appeared on patient's nose.Site states, "patient received a full thickness burn to nose." cynosure lutronic field service engineer (fse) arrived on site to perform device evaluation.During this time cynosure lutronic fse confirmed device had "error 63 faulty power module." cynosure lutronic fse was unable to complete repair during this visit.On the second fse visit, the device was brought back to the cynosure lutronic (b)(6) location for further repair.The device had the pumping board assembly replaced and the error code was successfully cleared.The device was subjected to final testing at the westford location with passing results.It is unknown if the error code observed contributed to the reported event.Cynosure lutronic clinical reached out to the site to collect additional information.Cynosure lutronic clinical determined the event to be inconclusive.Review of the treatment parameters used were found to be within the recommended settings within the quick start guide (qsg).The patient was prescribed bacitracin as a preventative.Cynosure lutronic clinical requested images of the reported side effects from the site, however, none were provided.The patient has not been seen for a follow up and there has been no intervention reported by the provider site.Due to patient experiencing full thickness burn, this is considered a serious 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: 22750107
• Report Number: 1222993-2025-00020
• Device Sequence Number: 21221994
• Product Code: GEX
• UDI-Device Identifier: 08809447652542
• UDI-Public: 08809447652542
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Type of Report: Initial
• Report Date (Section B): 08/08/2025
• Report Date (Section F): 08/08/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1110200230
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/09/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• 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: Male
• Date Report Sent to FDA: 08/08/2025