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

Model Number	AS-BM-00055
Medical Device Problem Codes	Failure to Deliver Energy (1211); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2026
Type of Reportable Event	Malfunction

• 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: david pluhar ; 333 george washington hwy; smithfield, RI 02917 ; +1(866)222-5276
• MDR Report Key: 50148444
• Report Number: 3021550489-2026-00010
• Device Sequence Number: 18818654
• Product Code: ONG
• UDI-Device Identifier: 00850039149047
• UDI-Public: (01)00850039149047(11)230104
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: k233803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AS-BM-00055
• Device Catalogue Number: AS-BM-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: 06/22/2026
• Initial Report FDA Received Date: 08/05/2026
• 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
• Patient Sex: Unknown