UNITY 00380657531684Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380657531684), received between Nov 25, 2025 and Feb 11, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT ASPIRATION FAILURE OCCURRED WITH PROBE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312982 ↗
• MalfunctionNov 27, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATION ISSUE OF THE CUTTER DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND IT WAS UNKNOWN HOW IT GOT COMPLETED. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23664036 ↗
• MalfunctionNov 25, 2025Failure to Cut; Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT ACTUATION ISSUE DURING CALIBRATION OF CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23653133 ↗