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	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the clarity ii system will not stop firing lasering pulse even when finger switch is not pressed.The site also reported that this happened twice when they were using the handpiece and the finger switch to discharge the laser.The operator did mention that they do not use the foot switch to discharge laser pulses and that no injuries were reported.Cynosure lutronic clinical determined that no patient or provider injury had occurred.A cynosure lutronic field service engineer (fse) arrived at the provider site and evaluated the device.The fse was unable to duplicate the reported incident of unintended continuous lasing when using the handpiece finger switch, however, the fse did identify multiple contributing factors that may have caused the reported issue.The device handpiece grounding (ferrite coil and internal grounding cable) were not installed and the device gui/system/mfc firmware were outdated.To correct the issue, the fse installed a ferrite coil, updated all firmware to the latest revisions.It was recommended that the customer replace the handpiece.Additionally, the fse observed a loose screw from the finger switch board that was not seated correctly and may have caused an electrical short and impaired switch operation.It is undetermined if this contributed to the reported incident, but as a precaution, the loose screw as secured, and properly reseated to the finger switch board.Post-service testing confirmed normal device operation with no recurrence of continuous firing, and all functional checks passed inspection.Since a device malfunction occurred, we are reporting this 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: 24225569
• Report Number: 1222993-2026-00006
• Device Sequence Number: 8392855
• Product Code: GEX
• UDI-Device Identifier: 08809447653723
• UDI-Public: 08809447653723
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/30/2026
• Report Date (Section F): 01/30/2026

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/07/2026
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2026
• 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: 01/30/2026