UNITY 00380650003317Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380650003317), received between Jul 17, 2025 and Sep 29, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Cut

  A health care professional reported that vitrectomy probe had poor cutting during surgery. The surgery was completed on the same day after replacing the cassette with another one. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50934793 ↗
• MalfunctionSep 22, 2026Failure to Cut

  A non-healthcare professional reported a failure of a failure of the cutting probe in the kit, stating that the probe would only aspirate and would not cut during vitrectomy surgery. The surgery was completed on same day, after replacing the product with new one. There was patient contact with suspect product but no impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853746 ↗
• InjuryAug 7, 2026Suction Problem

  A non-healthcare professional reported that during a vitrectomy procedure and ophthalmic vitrectomy, probe failed to build the aspiration. The vitreous was attached to the port resulted in traction on the retina and the surgeon had to perform laser treatment to repair the retina. An advisory message was also displayed during the procedure. The procedure was completed on the same day by replacing the product with another one. The current condition of the patient was unknown. Additional information has been requested and none received till date.

  Patient problems: Retinal Tear

  MAUDE report 50172773 ↗
• MalfunctionFeb 27, 2026Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE DID NOT ACHIEVE VACUUM BEFORE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED ON SAME DAY, BUT IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO INFORMATION REPORTED ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24468837 ↗
• MalfunctionFeb 2, 2026Failure to Cut

  A NURSE REPORTED THAT PROBE WAS NOT CUTTING BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING CASSETTE FOR PROBE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232414 ↗
• MalfunctionJan 20, 2026Suction Problem; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT NO ASPIRATION AND CUTTING WAS POSSIBLE DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24113031 ↗
• MalfunctionJan 20, 2026Suction Problem; Failure to Cut

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT NO ASPIRATION AND CUTTING WAS POSSIBLE DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24113028 ↗
• MalfunctionJan 6, 2026Suction Problem; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS NO CUTTING OR ASPIRATION AS THE CUTTER COULD NOT BE PRIMED OR TUNED BEFORE 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 23974462 ↗
• MalfunctionDec 22, 2025Suction Failure; Suction Failure

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT SUCTION WAS FAILED DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED BY REPLACING ANOTHER PACK. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23862591 ↗
• MalfunctionNov 18, 2025Failure to Cut; Failure to Cut

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER NOT CUTTING BEFORE THE VITRECTOMY 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 23579601 ↗
• MalfunctionSep 18, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT SMALL AMOUNT OF BALANCED SALT SOLUTION ENTERED IN THE EYE WHILE ON FLUID AIR EXCHANGE DURING THE VITREO-RETINAL SURGERY. THE SURGERY WAS COMPLETED, AND THE PRODUCT REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081633 ↗
• MalfunctionSep 11, 2025Suction Problem; Appropriate Device Problem Term/Code Not Available; Suction Problem; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED THAT LOST VACUUM MULTIPLE TIMES DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED BY REPLACING WITH NEW CASSETTE. THERE WAS NO PATIENT IMPACT. THIS REPORT PERTAINS TO CASSETTE INVOLVED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025663 ↗
• MalfunctionSep 8, 2025Material Twisted/Bent; Material Twisted/Bent

  A CUSTOMER REPORTED THAT THE TIP OF THE PROBE WAS BENT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22993752 ↗
• MalfunctionAug 14, 2025Suction Problem; Infusion or Flow Problem; Suction Problem; Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT THE LOW IRRIGATION PRESSURE AND NO VACUUM OR EXTRUSION DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22808520 ↗
• MalfunctionJul 24, 2025Suction Problem; Appropriate Device Problem Term/Code Not Available; Suction Problem; Appropriate Device Problem Term/Code Not Available

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE ERROR MESSAGE OF INTRAOCULAR PRESSURE CONTROL ISSUE WAS DISPLAYED ALONG WITH ASPIRATION DID NOT WORK DURING UNKNOWN TIMING. THE SURGERY WAS COMPLETED AFTER REPLACING THE CASSETTE WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION CONFIRMED THAT THE PROCEDURE WAS A VITRECTOMY SURGERY ON THE RIGHT EYE, AND THE EVENT OCCURRED DURING SURGERY. THE REPORTED SYMPTOMS WERE RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 22584993 ↗
• MalfunctionJul 18, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED THAT WHEN PEDAL WAS DEPRESSED NO AUDITORY SOUNDS OR FUNCTIONALITY OF THE VITRECTOMY PROBE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY DETAILS WERE UNKNOWN. NO PATIENT IMPACT WAS REPORTED. THIS REPORT PERTAINS TO PROBE INVOLVED IN THIS REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22543087 ↗
• MalfunctionJul 17, 2025Suction Problem; Defective Device; Suction Problem; Defective Device

  A CUSTOMER REPORTED THAT THE CUTTER VACUUM COULD NOT WORK AT AN UNKNOWN TIMING. IT WAS UNKNOWN WHETHER THE SURGERY WAS COMPLETED OR NOT. THE PROCEDURE DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. THIS REPORT PERTAINS TO THE PROBE INVOLVED IN THIS REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22528647 ↗
• MalfunctionJul 17, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A CUSTOMER REPORTED THAT IN AN OPHTHALMIC CONSOLE, THE VACUUM CUTTER WAS NOT FUNCTIONING. ALTHOUGH THE LED INDICATED THAT THE SYSTEM WAS OPERATIONAL, IT WAS NOT. DURING FAX, THE AIR DID NOT WORK, AND WITH AN OPHTHALMIC ACCESSORY, THE DIATHERMY REMAINED ACTIVE FOR A FEW SECONDS AFTER THE SURGEON RELEASED THE FOOT PEDAL AND THE PATIENT¿S EYE WAS STABILIZED. THE PROCEDURE WAS THEN SWITCHED TO A DIFFERENT CONSOLE. THE PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 22528645 ↗