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

Model Number	AS-BM-00055
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Radiation Burn (1755)
Date of Event	03/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An 80-year-old patient was treated using the ultraclear system on the legs.The treatment was superficial and produced significantly more tissue damage than expected by the doctor.Both legs had poor healing on the lower leg.Investigation revealed the patient had inflammation in both legs prior to treatment.Ultraclear treatment on the legs takes more time to heal than other areas of the body in the best conditions.The patients pre-existing inflammation should never have been treated with the ultraclear especially at the patient's advanced age.This was an inappropriate candidate for this treatment.

• Brand Name: ULTRACLEAR
• Common Device Name: FRACTION 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: 22286706
• Report Number: 3021550489-2025-00003
• Device Sequence Number: 8467305
• Product Code: GEX
• UDI-Device Identifier: 00850039149047
• UDI-Public: (01)00850039149047(11)231208
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: AS-BM-00055
• Device Catalogue Number: AS-BM-00055
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Other
• Patient Age: 80 YR
• Patient Sex: Female