UNITY 00380650003836Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380650003836), received between Jul 23, 2025 and Sep 22, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Suction Problem

  A physician reported that the vitreous cutter failed to aspirate 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 50850335 ↗
• MalfunctionSep 22, 2026Infusion or Flow Problem

  A physician reported that infusion failure 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 50850050 ↗
• MalfunctionAug 13, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231896 ↗
• MalfunctionJan 14, 2026Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THE IRRIGATION STOPPED WHEN INFUSION CANNULA WAS INSERTED INTO TROCAR CANNULA DURING THE CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065489 ↗
• MalfunctionJan 13, 2026Suction Failure

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS DISPLAY OF ADVISORY AND THE ASPIRATION OF VITRECTOMY PROBE WAS BLOCKED BEFORE CATARACT AND VITRECTOMY COMBINATION SURGERY. THIS COULD NOT BE RESOLVED DESPITE TRYING TO REPRIMING THE CASSETTE. THE SURGERY WAS COMPLETED ON THE SAME DAY BUT WITH PACK OF ANOTHER LOT. THERE WAS NO PATIENT CONTACT WITH SUSPECT PRODUCT. THIS REPORT PERTAINS TO VITRECTOMY PROBE INVOLVED IN REPORTED EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050351 ↗
• MalfunctionJan 7, 2026Air/Gas in Device

  A PHYSICIAN REPORTED THAT DURING CATARACT AND VITRECTOMY COMBINATION SURGERY, AIR FROM INFUSION WAS MIXED. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE ON THE SAME DAY. THERE WAS PATIENT CONTACT BUT NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23987590 ↗
• MalfunctionDec 24, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT CUTTER WAS ACTUATED, BUT IT HARDLY ASPIRATED DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PRODUCT WAS CONTACTED WITH THE PATIENT BUT THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23887764 ↗
• MalfunctionDec 24, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER ACTUATION ISSUE OCCURRED DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23886234 ↗
• MalfunctionDec 1, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE CUTTER COULD NOT CUT, RESULTING IN ANTERIOR CHAMBER INSTABILITY IN EYE DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 23677728 ↗
• 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 THE CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23579447 ↗
• MalfunctionNov 12, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT ASPIRATION OF A CUTTER DID NOT WORK DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE CONDITION OF ACTUATION AND CUTTING 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 23530649 ↗
• MalfunctionNov 3, 2025Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT WHEN A TROCAR BLADE WAS INSERTED INTO A PATIENT'S EYE, THE TROCAR COULD NOT BE HELD IN THE EYE AND IT WAS NOT RELEASED FROM THE BLADE WHEN THE TROCAR BLADE WAS PULLED OUT OF THE EYE, IT CAME OUT WITH THE TROCAR ON DURING VITRECTOMY SURGERY. THE PRODUCT WAS REPLACED TO COMPLETE THE SURGERY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23448669 ↗
• MalfunctionJul 30, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A PHYSICIAN REPORTED THAT THE IRRIGATION WAS COMING OUT NORMALLY BUT WHEN SWITCHED TO FLUID AIR EXCHANGE MODE, THE AIR DID NOT COME OUT DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE PROCEDURE WAS COMPLETED BY INCREASING THE PRESSURE AND ADJUSTING THE LINE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666020 ↗
• MalfunctionJul 24, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT ACTUATION FAILURE OF THE CUTTER OCCURRED DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. 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 22585155 ↗
• MalfunctionJul 23, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT ASPIRATION STOPPED DURING ULTRASOUND (US) OR IRRIGATION/ASPIRATION (IA) MODE OF CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). TURN OFF THE ERROR CODE AND REPEAT TURNING OFF AND ON CONTINUOUS IRRIGATION TO COMPLETE SURGERY. 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 22573941 ↗