MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II

Medical Device Problem Code	Operating System Version or Upgrade Problem (2997)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a clarity ii device was firing without the button being pressed.The device also reported not to recognize spot sizes correctly, and is powering off and on.Lastly, the device was reported to display "check icd" error message.There was no patient injury reported in this case.A trained cynosure lutronic field service engineer (fse) went to the treatment provider site for a device evaluation.During this time, the fse did observe the reported firing without the button being pressed.To correct this issue the handpiece was replaced and the firmware was upgraded (gui 1.09 sys 1.08 mfc 1.04, hp 1.05).It was observed that the icd being utilized is the non-eco 780g and to correct the icd issue the fse installed the eco icd in the device.Lastly, the fse ran burn sample tests with passing results, there was no indication of spot size issues.The device passed all final tests and meets published specifications.A member of the cynosure lutronic clinical team confirmed that there was no patient or provider injury reported during this incident.Since a reported malfunction occurred and there is potential serious injury, we are reporting this as an aro event.

• 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: 24136698
• Report Number: 1222993-2026-00003
• Device Sequence Number: 20191141
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: 08809447653723
• 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): 01/21/2026
• Report Date (Section F): 01/21/2026

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/22/2025
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/21/2026