MAUDE Adverse Event Report: Acclaro Corporation UltraClear; Fractional Mid-IR Laser

Model Number	AS-WB-00055
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Atrophy (4913)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Initially reported via the esg unified submission portal on 09/02/2026.Incorrect file type submitted with the initial report.This is a resubmission with the correct file type.On (b)(6)2026 the patient reached out directly to acclaro's clinical team.This was forwarded to acclaro qa for investigation.The patient reported fat loss under the eye as the result of ultraclear treatment.The patient reported receiving two treatments 2 days apart.The fat loss reported was noted after the second treatment.The treatments were performed on (b)(6)2026.On (b)(6)2026 the patient escalated their complaint to the clinic.The patient sought the opinion of a second dermatologist.The second dermatologist confirmed the fat loss.On 08/27/2026 acclaro qa received the following documents: completed global impact form email communication between the clinic and patient patient treatment consent forms photographs of the patient throughout treatment and healing process on 09/01/2026 acclaro qa received a letter from the second dermatologist confirming the fat loss in the under eye and treatment with tear trough fillers.Reportability assessment was performed on 09/02/2026.

• 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: david pluhar ; 333 george washington hwy; smithfield, RI 02917 ; +1(866)222-5276
• MDR Report Key: 50897738
• Report Number: 3021550489-2026-00012
• Device Sequence Number: 6001538
• Product Code: ONG
• UDI-Device Identifier: 00850039149429
• UDI-Public: (01)00850039149429(11)251031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: k233803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Initial Report FDA Received Date: 09/25/2026
• 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: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female