UNITY 00380650004840Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380650004840), received between Aug 13, 2025 and Sep 30, 2026 — classified as 21 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Improper Flow or Infusion

  A healthcare professional reported that air infusion failure (did not come out even though the air was put on) occurred during vitrectomy surgery. The surgery was completed on the same day after replacing the product with a new infusion line. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943432 ↗
• MalfunctionSep 29, 2026Suction Problem

  A physician reported that the aspiration pressure did not rise during surgery. The procedure type was unknown. The surgery was completed on same day after replacing the product with another one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934794 ↗
• MalfunctionSep 28, 2026Suction Problem

  A physician reported that the aspiration pressure did not increase during the irrigation/aspiration mode. The surgery was completed on the same day after the product was replaced with another one. The procedure type was unknown. There was patient contact with the suspect product; however, no impact occurred to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916948 ↗
• MalfunctionSep 28, 2026Incomplete or Inadequate Connection

  A healthcare professional reported that the error message (loose tip) occurred, which made prime impossible before vitrectomy surgery. The surgery was completed on same day after replacing the product with another one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916281 ↗
• MalfunctionSep 22, 2026Failure to Cut

  A physician reported that the cutting failure of cutter occurred during surgery. The procedure type was unknown. The surgery was completed on the same day by replacing the product with new one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856446 ↗
• MalfunctionAug 12, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218761 ↗
• MalfunctionFeb 27, 2026Obstruction of Flow

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE TIP OF AN INFUSION LINE WAS CLOGGED WITH ONE PAK DURING SET UP FOR VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED POST REPLACEMENT OF CONSOLE BUT NOTHING WAS WRONG WITH CONSOLE AS IT WAS CONFIRMED THAT THE INFUSION CANNULA WAS FOUND TO BE CLOGGED. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466911 ↗
• MalfunctionFeb 19, 2026Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE ASPIRATION OR VACUUM IN THE VITRECTOMY PROBE STOPPED WORKING DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER TAKING A NEW PAK (FLUIDICS MANAGEMENT SYSTEM AND TUBING). THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24386174 ↗
• MalfunctionFeb 12, 2026Suction Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE VITRECTOR COULD NOT ASPIRATE DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PACK WITH ANOTHER ONE. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321971 ↗
• MalfunctionFeb 11, 2026Fluid/Blood Leak

  A HEALTH CARE PROFESSIONAL REPORTED THAT LEAKED TROCARS DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AND IT WAS UNKNOWN HOW IT GOT COMPLETED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24311962 ↗
• MalfunctionJan 14, 2026Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE CUTTER STOPPED ACTUATING DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065269 ↗
• MalfunctionDec 9, 2025Improper Flow or Infusion; Improper Flow or Infusion

  ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT THE AIRFLOW WAS TESTED BEFORE USING THE MACHINE. THE AIR ONLY WORKED AT THE BEGINNING, WITH THE INJECTION OF A SMALL BUBBLE. NO MESSAGE WAS DISPLAYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23754940 ↗
• MalfunctionDec 1, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE SURGEON EXPERIENCED LOSS OF INFUSION, SO THE EYE SOFTENED DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 23682492 ↗
• MalfunctionNov 28, 2025Suction Problem; Suction Problem

  AN OPHTHALMIC SURGEON REPORTED THAT THE ASPIRATION FAILURE OCCURRED DURING IRRIGATION ASPIRATION (I/A) STEP OF THE CATARACT [WITH INTRAOCULAR LENS (IOL) IMPLANT] SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THE PRODUCT WAS CONTACTED WITH PATIENT BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669873 ↗
• MalfunctionNov 19, 2025Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER STOPPED ASPIRATING IN THE MIDWAY DURING VITRECTOMY SURGERY. A NEW PAK WAS OPENED TO COMPLETE THE SURGERY ON THE SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23595424 ↗
• MalfunctionNov 18, 2025Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCTS.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 23579670 ↗
• MalfunctionOct 15, 2025Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN ISSUE WITH FLUCTUATED ASPIRATION, GOING UP AND DOWN DURING PHACOEMULSIFICATION (PHACO) MODE OF THE SURGERY. THE SURGERY DETAILS AND PATIENT IMPACT DETAILS WERE UNKNOWN. THIS REPORT PERTAINS TO TWO OF THE TWO REPORTS FROM THE SAME FACILITY. THIS REPORT PERTAINS TO CASSETTE INVOLVED IN THIS REPORTED EVENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED THAT THE COMBINED SURGERY WAS COMPLETED WITH SAME PAK AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278510 ↗
• MalfunctionSep 17, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THERE WAS NO INDICATION OF INFLOW, AND NO IRRIGATION ENTERED THE EYE DURING SURGERY. THERE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT. THE PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071686 ↗
• MalfunctionSep 15, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THE WATER WAS WEAK ALTHOUGH THE SCREEN DISPLAY "INFLOW" DURING SURGERY. THE SURGERY WAS 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 23049492 ↗
• MalfunctionSep 2, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  UPON FURTHER ASSESSMENT, IT HAS BEEN CONFIRMED THAT THE TROCAR IN PACK DAMAGED, HAD BURR/EDGE PROTRUDING OUT WAS IDENTIFIED TO BE A TROCAR BENT CANNULA ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932221 ↗
• MalfunctionAug 13, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A PHYSICIAN REPORTED THAT THERE WAS NO AIR COMING OUT FROM THE INFUSION CANNULA DURING SURGERY. THE TYPE OF PROCEDURE WAS UNKNOWN. 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 22791929 ↗