UNITY 00380650004789Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00380650004789), received between Sep 2, 2025 and Sep 29, 2026 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (8 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Suction Problem; Failure to Cut

  A healthcare professional reported that the vitrectome malfunctioned during surgery, as it failed to perform both cutting and vacuum functions. The procedure type was unknown. Even after reducing the cutting speed to 10000 cuts per minute (CPM) and changing the pump of the console the issue was not resolved. The procedure was able to continue after the affected vitrectome was replaced with a new one. It was unknown how the surgery was completed. There was no information about the patient impact.Additional information could not be obtained because the initial reporter declined further follow-up contact.

  Patient problems: Insufficient Information

  MAUDE report 50934512 ↗
• MalfunctionSep 29, 2026Use of Device Problem

  A customer reported that faulty cutter during ophthalmic surgery. The surgery was completed but it was unknown how the surgery was completed. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927474 ↗
• MalfunctionSep 28, 2026Suction Problem; Failure to Cut

  A customer reported that stopped cutting and sucking vitreous after a while during vitrectomy surgery. A new pak was opened to complete the surgery. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914020 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  A physician reported that there was leakage occurred due to trocar valve failure during surgery. 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 50854383 ↗
• MalfunctionSep 17, 2026Obstruction of Flow

  A physician reported that the clogging in the cassette 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 50804767 ↗
• MalfunctionJul 27, 2026Obstruction of Flow

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 50032641 ↗
• MalfunctionMay 15, 2026Dull, Blunt

  A NURSE REPORTED THAT AN TROCAR KNIFE (ENTRY SYSTEM) WAS FOUND NOT SHARP (DULL). THE SCHEDULED SURGERY WAS VITRECTOMY SURGERY. THERE WAS NO INFORMATION ABOUT ANY PATIENT IMPACT. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 25179952 ↗
• MalfunctionMar 18, 2026Suction Problem

  A PHYSICIAN REPORTED THAT DURING THE VITRECTOMY SURGERY IN VACUUM MODE, ENCOUNTERED A PROBLEM WITH THE VACUUM. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24627296 ↗
• MalfunctionMar 6, 2026Defective Device; Appropriate Device Problem Term/Code Not Available

  A NURSE REPORTED THAT ERROR CODE DISPLAYED WHICH PREVENTED SILICONE INJECTION DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO APPARENT IMPACT. THE SURGERY WAS EXTENDED BEYOND THE EXPECTED TIME DUE TO MULTIPLE ATTEMPTS TO OPERATE THE UNIT THROUGH RESTARTS AND RE-PRIMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531843 ↗
• MalfunctionMar 6, 2026Suction Problem

  A NURSE REPORTED THAT ERROR CODE DISPLAYED WHICH PREVENTED ASPIRATION FROM THE VITRECTOMY PROBE DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO APPARENT IMPACT. THE SURGERY WAS EXTENDED BEYOND THE EXPECTED TIME DUE TO MULTIPLE ATTEMPTS TO OPERATE THE UNIT THROUGH RESTARTS AND RE-PRIMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24531833 ↗
• MalfunctionMar 3, 2026Break

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT TIP OF THE PROBE WAS BROKEN DURING THE CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493766 ↗
• MalfunctionDec 21, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT PROBE SUDDENLY STOPPED CUTTING AND ASPIRATION WAS NORMAL DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY LOWERED THE CUT RATE AND THEN WORKED FINE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860312 ↗
• MalfunctionDec 4, 2025Failure to Cut; Failure to Cut

  A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE STOPPED CUTTING DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23715141 ↗
• InjuryDec 4, 2025Obstruction of Flow; Obstruction of Flow

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING VITREO-RETINAL SURGERY, THE SURGEON PLACED THE FIRST TROCAR IN THE EYE, INITIATED INFUSION TO CLEAR AIR, AND CONNECTED THE INFUSION LINE TO THE CANNULA. A SECOND AND THIRD CANNULA WERE THEN INSERTED, AND BY THE TIME THE THIRD WAS PLACED, THE EYE WAS NOTED TO FEEL SOFTER. INFUSION PRESSURE WAS SET AT 26, AND THE POSTERIOR EPITHELIAL LAYER (PEL) WAS PROPERLY ADJUSTED. FURTHER, WHEN THE VITRECTOMY PROBE WAS INTRODUCED, THE EYE IMMEDIATELY SOFTENED FURTHER AND CHOROIDALS BECAME VISIBLE. NO ADVISORIES APPEARED, AND THE INFUSION LINE WAS ON AND UNCLAMPED. A SECOND ATTEMPT PRODUCED THE SAME RESULT, WITH NO INFUSION REGISTERING ON THE INFLOW AND PERSISTENT CHOROIDALS. THE CANNULA WAS THEN REMOVED TO CHECK FOR OBSTRUCTION. AT ALTERNATE INFUSION PRESSURE OF 60, FLUID WAS DRIPPING, AND THE SURGEON USED HIS FINGERS TO PULL AT THE METAL TIP OF THE INFUSION CANNULA DUE TO WHICH A STRAND OF VITREOUS STARTED TO WICK AWAY AS IF IT WAS INCARCERATED INTO THE INFUSION LINE AND THEN FLUID BEGAN TO RUN. THE LINE WAS RECLAMPED, RETURNED TO NORMAL PRESSURE, REINSERTED, AND INFUSION WAS RESTARTED. ALTHOUGH PROPER INFUSION WAS RESTORED, THE CHOROIDALS DID N

  Patient problems: Eye Injury; Intraocular Pressure Decreased

  MAUDE report 23714297 ↗
• MalfunctionDec 2, 2025Fitting Problem; Dull, Blunt; Material Protrusion/Extrusion; Fitting Problem; Dull, Blunt; Material Protrusion/Extrusion

  A HEALTHCARE PROFESSIONAL REPORTED THAT IT WAS VERY DIFFICULT FOR THE SURGEON TO INSERT THE TROCAR CANNULA AND COULD FIND SOMETHING LIKE A HOOK AT THE DISTAL END AT AN UNKNOWN TIMING OF VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN HOW IT WAS COMPLETED. THERE WAS NO REPORTED INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23690985 ↗
• MalfunctionNov 28, 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 23671590 ↗
• MalfunctionNov 20, 2025Failure to Cut; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PROBE WAS NOT CUTTING. THE SURGERY WAS COMPLETED AFTER REPLACING ANOTHER PROBE. PROCEDURE TYPE AND PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23602330 ↗
• MalfunctionNov 19, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A NURSE REPORTED THAT WHEN INFUSION WAS CHANGED TO AIR AT THE END OF SURGERY, THE AIR FLOW SUDDENLY STOPPED AND THE EYE BECAME SOFT DURING VITRECTOMY SURGERY. THE CASSETTE WAS REPLACED TO COMPLETE THE SURGERY. THERE WAS NO INFORMATION ABOUT PATIENT CONDITION. THIS REPORT PERTAINS TO CASSETTE INVOLVED IN THIS REPORTED EVENT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 23595218 ↗
• 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 23579666 ↗
• MalfunctionNov 11, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY IN AN OPHTHALMIC SYSTEM WHEN INFUSION WAS CHANGED TO AIR, THE AIR FLOW SUDDENLY STOPPED, AND THE PATIENT'S EYE BECAME SOFT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER CHANGING THE CASSETTE. THE CURRENT CONDITION OF PATIENT IS UNKNOWN. THIS REPORT IS TWO OF TWO SUBMITTED FROM THE SAME FACILITY AND PERTAINS TO THE CASSETTE INVOLVED IN THE EVENT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 23523104 ↗
• MalfunctionOct 24, 2025Suction Problem; Infusion or Flow Problem; Suction Problem; Infusion or Flow Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN ERROR CODE WAS DISPLAYED, AND THE VACUUM COULD NOT RISE, ALTHOUGH IT WAS RELEASED, AND THE FOOT SWITCH COULD NOT GO UP AND INFUSION DID NOT GO UP FROM OFF TO ON 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 PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23379909 ↗
• MalfunctionOct 15, 2025Failure to Cut; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE CUTTER COULD NOT ACTUATE AND COULD NOT CUT DURING THE VITRECTOMY RETINAL SURGERY. THE ASPIRATION WAS WORKING. THE SURGERY WAS COMPLETED BY REPLACING CUTTER. THE PATIENT WAS CONTACTED WITH PRODUCT BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299697 ↗
• InjuryOct 15, 2025Suction Problem; Free or Unrestricted Flow; Improper Flow or Infusion; Suction Problem; Free or Unrestricted Flow; Improper Flow or Infusion

  THE PHYSICIAN REPORTED THAT AN OPHTHALMIC OPERATING SYSTEM WAS USED FOR THE VITRO RETINAL SURGERY. DURING THE SURGERY THE SYSTEM PRESSURE WAS TOO HIGH, AND PHYSICIAN ATTEMPTED TO SWITCH TO AIR MODE, BUT SYSTEM DID NOT DELIVER THE AIR AND PATIENT HAD POOR VISION, SEVERE HYPOTONY AND PATIENT RECEIVED DECALINE INJECTION TO FLATTEN THE RETINA. THE SURGEON ATTEMPTED TO INJECT SILICONE, BUT INSTEAD OF USING THE TROCAR AS RECOMMENDED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER SYSTEM. THE CURRENT CONDITION OF THE PATIENT CONDITION WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Blurred Vision; Intraocular Pressure Decreased

  MAUDE report 23298053 ↗
• MalfunctionOct 15, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE STOPPED ASPIRATING AND CUTTING DURING VITREO RETINAL SURGERY. THE SURGERY WAS COMPLETED AFTER CHANGED WITH NEW PACK. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288162 ↗
• MalfunctionSep 18, 2025Fluid/Blood Leak; Improper Flow or Infusion; Fluid/Blood Leak; Improper Flow or Infusion

  A CUSTOMER REPORTED A LEAKY VALVED CANNULA AND A LACK OF AIR ENTERING THE EYE, WHICH RESULTED IN THE PATIENT'S EYE STARTING TO COLLAPSE WITH CHOROIDAL DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE REPLACE ALL THE INFUSION TUBING UP TO THE CASSETTE, AND THEN BACK INTO THE EYE UNDER AIR AND AIR BEGAN TO FLOW NORMALLY AT THAT TIME. THERE WAS NO PATIENT IMPACT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Injury

  MAUDE report 23082167 ↗