UNITY 00380657531790Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380657531790), received between Nov 12, 2025 and Nov 12, 2025 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 5, 2025Open, Classified

   Due to incomplete seals in the pouch which provide the sterile barrier.

   Z-0304-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT PROBE WAS NOT ASPIRATED DID NOT WORK DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PROBE WITH THE SAME PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23529790 ↗