UltraClear AS-WT-00055Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850039149016), received between Oct 24, 2023 and Sep 30, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Misfocusing” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Misfocusing

  Patient problems: Erythema; Superficial (First Degree) Burn

  MAUDE report 50947757 ↗
• InjuryOct 24, 2023Off-Label Use; Off-Label Use

  ACCLARO BECAME AWARE THAT THE DEVICE WAS USED OFF-LABEL IN PARAMETERS THAT ARE NOT SUITABLE FOR THE MODALITY THAT THE DR. UTILIZED ON HIS PATIENT. DURING THE HEALING PROCESS THE PATIENT DEVELOPED A LOCAL INFECTION THAT THE PHYSICIAN FELT IMPORTANT TO RESOLVE. PATIENT HAS FULLY HEALED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 17995836 ↗