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	Scar Tissue (2060); Hypopigmentation (4838)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reached out directly to acclaro to report this complaint on (b)(6) 2026 in regard to a treatment that occured on (b)(6) 2025.The patient reported trackmarks on the neck after a laser coring treatment and persistent erythema.Laser coring delivers laser energy to a small region at high depths of 0.5mm to 4mm.Acclaro clinical reached out to the treating physician to discuss the issue.The treating physician reported using laser coring mode at 2% coverage and 2mm drill depth.2mm depth is very aggressive treatment and has been known to cause trackmarks (also known as stamping, pixelated stamping, or gridmarks) and delayed healing in some cases when used on an inappropriate patient and/or anatomical region.The trackmarks present in the photographs provided for this case are atypical.In most cases they appear as pinpoint indentations in a grid pattern.In this case they appear as raised hypopigmented dots.The typical trackmarks are known to heal with time, though it may be a matter of months.In one other reported case we have seen trackmarks present in this way, internal record number cmp-000065.In that case the treatment was performed in a similar region (neck) and at drill depths of 1mm.The patient cancelled any follow up appointments.Acclaro determined this was not reportable as the physician stated they expected the patient to heal and no interventions were taken.In this case, the patient is continuing to work with the treating physician and they have offered to provide her with topical treatments and other interventions to resolve the visible trackmarks.The root cause for this complaint is determined to be too aggressive parameter selection for the patient and anatomical region being treated.

• 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: 24924660
• Report Number: 3021550489-2026-00004
• Device Sequence Number: 10299699
• Product Code: GEX
• UDI-Device Identifier: 00850039149429
• UDI-Public: (01)00850039149429(11)240626
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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 Sex: Female
• Patient Race: White