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

Model Number	AS-BK-00055
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was reported as having lesions on face that developed after ultraclear treatment.Photographs provided of the first 11 days post treatment showed redness and crusting through the first 5 days developing into open lesions by day 11.The treating physician prescribed hypochlorous acid spray on day 5 to reduce redness and inflammation.On day 9 the patient was prescribed keflex (cephalexin, an antibiotic) as bacterial infection was suspected.Members of acclaro's medical advisory board (mab) reviewed the provided photographs.The mab stated that had these symptoms presented in clinic they would have prescribed 1000mg of valtrex 3x per day and culture the lesions as soon as an outbreak occurred.Mab stated they would prescribe keflex or a similar antibiotic and if the culture results indicated mrsa, they would prescribe doxycycline or tetracycline.This information was communicated with the reporting clinic.The clinic stated they did not prescribe valtrex as there was no history of herpes in the patient, so they prescribed keflex.The clinic cultured the lesions and the results indicated mrsa.The patient was then prescribed valtrex and tetracycline.It is the opinion of acclaro's mab and clinical department that the reported adverse event was a herpes outbreak due to viral reactivation which led to a mrsa infection.The clinic provided follow up photographs of the patient on (b)(6) 2026.The photographs showed no active lesions at that point and the clinic reported she was doing much better.The root cause of this complaint is determined to be a herpes outbreak due to viral reactivation that led to a mrsa infection.Herpes is a listed contraindication for ultraclear treatment.
Additional Manufacturer Narrative
Cause traced to contraindicated use (herpes and similar viruses) however the treating physician reported no known history of herpes.

• 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 02917
• Manufacturer Contact: jose valerio ; 333 george washington hwy; smithfield 02917
• MDR Report Key: 24388419
• Report Number: 3021550-2026-00002
• Device Sequence Number: 21402363
• Product Code: GEX
• UDI-Device Identifier: 00850039149023
• UDI-Public: (01)00850039149023(11)230118
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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-BK-00055
• Device Catalogue Number: AS-BK-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: 01/20/2026
• Initial Report FDA Received Date: 02/19/2026
• 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: 61 YR
• Patient Sex: Female
• Patient Race: White