UNITY 00380650002501Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380650002501), received between Aug 14, 2025 and Sep 30, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Cut

  A physician reported that actuation failure of the cutter occurred during surgery. The procedure type was unknown. The surgery was completed after replacing it with another product. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943275 ↗
• MalfunctionSep 29, 2026Suction Problem

  A physician reported that a vitrectomy probe aspiration issue occurred during a vitrectomy surgery. The surgery was completed on the same day after the product was replaced with another one. There was patient contact with the suspected product; however, no impact occurred to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929026 ↗
• MalfunctionMar 6, 2026Suction Problem

  A PHYSICIAN REPORTED THAT ASPIRATION COULD NOT BE ACHIEVED DUE TO BACKFLOW THAT OCCURRED DURING THE SURGERY THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528334 ↗
• MalfunctionNov 30, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTER COULD NOT MOVE DURING CALIBRATION. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23677061 ↗
• MalfunctionAug 14, 2025Failure to Cut; Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT ACTUATION FAILURE OF THE CUTTER OCCURRED AND THE CUTTER STOPPED CUTTING DURING SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806058 ↗