MAUDE Adverse Event Report: LUTRONIC CORPORATION CLARITY II; Powered laser surgical instrument

Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient experienced a burn on a tattoo during a laser hair reduction treatment using a clarity ii device.The reported treatment occurred on (b)(6) 2025, the side effects were reported on (b)(6) 2025.Dr.(b)(6) the (b)(6) director was consulted in this case.Dr.(b)(6) stated "this is a full thickness burn with tissue loss.This is third degree.I would expect a scar and the wound heals in by secondary intention." the provider reported that topical antibiotics were prescribed as a preventative.Dr.(b)(6) recommended the following for post treatment care "once full closed, i would recommend silicon gel, massage and either micro needling or non-ablative laser resurfacing".It was determined that this case was due to user error.The laser hair reduction treatment was the intended treatment for the patient.Though the treatment parameters reported to be used are within the normal limits, during laser hair removal treatments the tattoo area must be strictly avoided.The clarity ii qsg states: "do not treat over or close to tattoos or permanent make up." in this case, the tattoo was inadvertently treated, which resulted in a burn, that was confirmed by the (b)(6) director.This case was determined to be reportable due to the observed full thickness burn with tissue loss in the supplied images related to this case.The clarity ii operators manual states that "side effects or complications may be experienced during treatment or shortly afterwards in certain regions, (periorbital, neck, chest)- erythema lasting longer than normal, purpura, tenderness, edema, damage to natural skin texture (scratching, crusting, blister, burn), hyperpigmentation or hypopigmentation, herpes simplex, bacterial and / or fungal infection, scarring, redness, irritation, burning sensation.In an effort to reduce the probability of reoccurrence, the treatment technique was reviewed and discussed with the provider.In addition, the (b)(6) director's assessment and recommendations were communicated to the treatment provider.
Event or Problem Description
A patients tattoo was accidently hit during laser hair reduction treatment with clarity ii device.

• Brand Name: CLARITY II
• Common Device Name: Powered laser surgical instrument
• Manufacturer (Section D): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer (Section G): LUTRONIC CORPORATION; lutronic center; 219 sowon-ro; deogyang-gu, goyang-si 10534 ; KS 10534
• Manufacturer Contact: nirav desai ; 3/5 carlisle road; westford, MA 01886 ; 9783940763
• MDR Report Key: 22054763
• Report Number: 3021199089-2025-00003
• Device Sequence Number: 17164756
• Product Code: GEX
• UDI-Device Identifier: 08809447652542
• UDI-Public: 08809447652542
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K183566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female