MAUDE Adverse Event Report: ACCLARO CORPORATION ULTRACLEAR; FRACTIONAL MID-IR LASER

Model Number	AS-WB-00055
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Atrophy (4913)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was treated with laser coring at 5% coverage and 1.5mm drill depth in the submental region, and 5% coverage and 1mm drill depth in the lower face.A second treatment pass over both treatment areas of clear mode at 35% coverage and 30um ring depth.Photographs show laxity in the submental region 4 weeks post treatment.Further photographs show that the laxity has not reduced 4 months post treatment.Acclaro clinical reached out to an acclaro key opinion leader (kol) for his clinical opinion of the case.The kol contacted is a dermatologist with signifcant experience using laser devices and specifically using the ultraclear device.The kol stated in email that he suspected with treatment depths this deep on the submental region of a thin patient it is likely that energy was delivered to the hypodermis resulting in fat injury and volume loss.He suspected that the laxity would improve over time but was unlikely to resolve completely on its own.He suggested a combination of treatments to remedy the laxity including further ultraclear treatment at a superficial level focusing on skin tightening in combination with biostimulatory volume restoration.Acclaro clinical met with the staff of the treating clinic to discuss the patient's specific case and to discuss parameter selection.After discussion the patient opted for further superficial ultraclear treatment with a focus on skin tightening but opted against other suggestions.Acclaro clinical discussed the need to use less aggressive settings and to cater drill depth to the specific regions and skin thickness of individual patients.Further a clinical training for all providers at the clinic is scheduled including an exercise in parameter selection.The root cause of this adverse event is determined to be too deep and aggressive coring settings in the submental region of a thin patient.

• Brand Name: ULTRACLEAR
• Common Device Name: FRACTIONAL MID-IR LASER
• Manufacturer (Section D): ACCLARO CORPORATION; 333 george washington hwy; smithfield RI 02917
• Manufacturer (Section G): ACCLARO CORPORATION; 333 george washington hwy; smithfield RI 02917
• Manufacturer Contact: jose valerio ; 333 george washington hwy; smithfield, RI 02917
• MDR Report Key: 24533796
• Report Number: 3021550-2026-00003
• Device Sequence Number: 18409874
• Product Code: GEX
• UDI-Device Identifier: 00850039149429
• UDI-Public: (01)00850039149429(11)250113
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210847
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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 Model Number: AS-WB-00055
• Device Catalogue Number: AS-WB-00055
• 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: 02/06/2026
• Initial Report FDA Received Date: 03/06/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Race: White