UNITY 00380650004857Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380650004857), received between Oct 24, 2024 and Sep 29, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (7 reports).

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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Suction Problem

  A physician reported that aspiration failure of cutter occurred during vitrectomy surgery. The surgery was completed on the same day by changing the product. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933779 ↗
• MalfunctionSep 23, 2026Suction Problem

  A physician reported that this report aspiration problem of cutter (vitrectomy probe) occurred during surgery. The procedure type was unknown. The surgery was completed on the same day by replacing the product with another one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865172 ↗
• MalfunctionSep 11, 2026Failure to Cut

  A nurse reported that cutter worked initially but stopped working middle of the surgery during vitrectomy surgery The surgery was completed on the same day, but it was unknown how the surgery was completed. There was no information about the patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50728556 ↗
• MalfunctionAug 20, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50339421 ↗
• InjuryAug 10, 2026Appropriate Device Problem Term/Code Not Available

  A customer reported that there was display of error code during cataract surgery (with intra ocular lens implantation) surgery in the right eye of a male elderly patient. The incident resulted in prolonged delay in the start and progression of the surgical procedures causing anxiety and discomfort in patient requiring supplemental sedation and oxygen therapy, as well as delaying their postoperative discharge. Although inpatient admission was not required; management was outpatient-based and the patient was prescribed with topical ophthalmic drops per standard post-cataract surgery protocol. There was no negative consequences on the patient and the patient was recovering.This report pertains to one of the two cassettes involved in reported events.

  Patient problems: Anxiety; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194805 ↗
• MalfunctionJul 7, 2026Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT VITRECTOMY PROBE COULD NOT CUT. THE SURGERY DETAILS AND PATIENT IMPACT DETAILS WERE UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25742802 ↗
• MalfunctionApr 2, 2026Obstruction of Flow; Improper Flow or Infusion; Appropriate Device Problem Term/Code Not Available

  A NURSE REPORTED THAT STOPPED PUMPING AIR INTO THE EYE AND PRODUCED AN UNUSUAL NOISE DURING FLUID AIR EXCHANGE FOR VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO REPORT OF PATIENT IMPACT. THIS REPORT PERTAINS TO CASSETTE INVOLVED IN THIS REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24763683 ↗
• InjuryMar 31, 2026Fluid/Blood Leak

  A HEALTH CARE PROFESSIONAL REPORTED THAT TROCAR WAS LEAKING AGAIN DURING SURGERY. AT THE END OF THE OPERATION, THE EYE WAS ONLY FILLED WITH BALANCED SALT SOLUTION (BSS) AND HAD TO BE SUTURED. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT THE SURGERY WAS COMPLETED BUT IT WAS UNKNOWN HOW IT GOT COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24742492 ↗
• MalfunctionMar 3, 2026Suction Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT CASSETTE STOPPED CREATING VACUUM DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE EQUIPMENT RECOMMENDED REPLACING THE CASSETTE, AND THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED AND NON-RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493293 ↗
• MalfunctionFeb 20, 2026Suction Problem

  A PHYSICIAN REPORTED THAT ALTHOUGH THE DRAIN BAG WAS NOT FILLED WITH FLUID, A MESSAGE SAYING THAT THE DRAIN BAG FULL WAS DISPLAYED. THE DRAIN BAG WAS FILLED WITH AIR DUE TO ASPIRATION FAILURE OF CUTTER DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399577 ↗
• MalfunctionJan 12, 2026Suction Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT VITRECTOR STOPPED ASPIRATING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24033117 ↗
• MalfunctionDec 18, 2025Suction Problem; Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT VITRECTOR WAS NOT ASPIRATING PROPERLY AT AN UNKNOWN TIMING OF VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING THE VITRECTOR. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23837144 ↗
• MalfunctionNov 18, 2025Air/Gas in Device; Air/Gas in Device

  A PHYSICIAN REPORTED THAT BUBBLES ENTERED IN THE IRRIGATION LINE AND PATIENT'S EYE DURING CATARACT AND VITRECTOMY COMBINED SURGERY. 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 23580645 ↗
• MalfunctionNov 18, 2025Air/Gas in Device; Air/Gas in Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT BUBBLES ENTERED IN THE IRRIGATION LINE AND PATIENT'S EYE DURING CATARACT AND VITRECTOMY COMBINED SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, NAD IT WAS UNKNOWN HOW IT GOT COMPLETED. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23580629 ↗
• MalfunctionOct 12, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT THE ALARM OCCURRED AND ASPIRATION WAS NOT POSSIBLE WHEN TRIED TO PERFORM ASPIRATION USING THE VACUUM CONTROL DURING SURGERY. THE CONDITION OF ACTUATING AND CUTTING IS UNKNOWN. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23275881 ↗
• MalfunctionOct 24, 2024Component Missing; Improper Flow or Infusion; Component Missing; Improper Flow or Infusion

  A PHYSICIAN REPORTED THAT THE FLUID AIR EXCHANGE (FAX) COULD NOT BE INSTALLED PROPERLY AND WAS FOUND TO HAVE A MISSING O-RING ON THE CONNECTOR BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520445 ↗