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

Model Number	AS-WB-00055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was treated with ultraclear and laser coring modalities on 03/16/2026.The treating physician reached out to acclaro on (b)(6) 2026 to report persistent pixelating stamping on the patient's cheeks.Photographs were provided clearly showing stamping.The photographs do not appear to show scarring (no hypopigmentation, no raised marks).The photographs are consistent with previous reports of pixelated stamping.The provided patient impact form has parameters for multiple modes on varying regions of the face.The stamping appears to be due to the laser coring treatment on the marionette lines.The coring parameters in this region were coverage of 4% and depth of 1mm.Gd-mk-00029 ultraclear quick reference guide rev c.Recommends coring coverage of 1-2%.The higher the coverage and depth parameters, the more likely for pixelated stamping to persist.The patient was prescribed prednisone for swelling post treatment, 40mg daily for 3 days.Persistent pixelated stamping is a known possible side effect of ablative laser treatments.It is most commonly associated with laser coring mode but has been seen with ultraclear mode.It is expected to resolve with time though in other cases follow up treatments with different modalities using the same device have been used to resolve the issue.Root cause for this complaint is likely due to individual differences in healing and coverage parameters slightly above recommended.Acclaro recommends using a test spot prior to performing treatments to test for individual responses.

• 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: 50161813
• Report Number: 3021550489-2026-00011
• Device Sequence Number: 18793455
• Product Code: ONG
• UDI-Device Identifier: 00850039149429
• UDI-Public: (01)00850039149429(11)250304
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K233803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: 07/08/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (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: 43 YR
• Patient Sex: Female
• Patient Race: White