UNITY 00380650003348Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380650003348), received between Feb 18, 2025 and Mar 6, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Obstruction of Flow

  A PHYSICIAN REPORTED THAT UNUSUAL ABNORMAL SOUNDS DURING THE SURGERY. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT REPLACING THE PRODUCT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530585 ↗
• MalfunctionJan 16, 2026Suction Problem; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE CUTTER WAS NOT CUTTING AND ASPIRATING DURING POSTERIOR 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 24092257 ↗
• MalfunctionJan 7, 2026Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT UNABLE TO ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION RECEIVED THAT ASPIRATION ISSUE OF PROBE OCCURRED. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE CUTTER WITH ANOTHER ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992931 ↗
• MalfunctionJan 5, 2026Break; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT TIP OF CUTTER WAS FOUND BROKEN DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE CUTTER WAS BENT INITIALLY DURING SURGERY. THE SURGEON REPOSITIONED IT AND CONTINUED THE PROCEDURE, BUT THE CUTTER STARTED MOVING ABNORMALLY. WHEN THE SURGEON TRIED TO RESTORE THE PROBE OUTSIDE THE EYE, IT BROKE. THERE WAS NO BREAKAGE INSIDE THE EYE AND NO FRAGMENT DROPPED INTO THE EYE. THE SURGERY WAS SUCCESSFULLY COMPLETED ON SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. THIS REPORT PERTAINS TO THE PROBE INVOLVED IN THIS REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23958462 ↗
• MalfunctionDec 2, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT THE VITRECTOR STOPPED CUTTING WHILE THE VITREOUS WAS FASTEN AT THE TIP BECAUSE, IT STILL WAS ASPIRATING BUT WITH NO CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. CUT RATED SLOWED DOWN FROM 30 K TO 10 K CUT RATE. THEN THE VITREOUS COULD GET FREE AND IT CONTINUED CUTTING FOR A WHILE UNTIL IT STOPPED AGAIN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23690984 ↗
• MalfunctionNov 26, 2025Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE ASPIRATION OF A CUTTER WAS WEAKER THAN USUAL DURING THE VITRECTOMY SURGERY. THE CONDITION OF ACTUATION AND CUTTING WAS UNKNOWN. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654884 ↗
• InjurySep 18, 2025Improper Flow or Infusion; 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: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082165 ↗
• 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: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23082163 ↗
• MalfunctionSep 12, 2025Improper Flow or Infusion; Infusion or Flow Problem; Improper Flow or Infusion; Infusion or Flow Problem

  A NURSE REPORTED THAT BALANCED SALT SOLUTION INFUSION DURING AIR EXCHANGE DURING VITREORETINAL SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23035212 ↗
• MalfunctionSep 2, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A NURSE REPORTED THAT A STREAM OF BSS (BALANCED SALT SOLUTION) FLOWED INTO THE EYE WHILE FLUID EXTRACTION UNDER AIR DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. 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 22931993 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY ON THE LEFT EYE, AN AIR FILLED RETINAL DETACHMENT SUDDENLY FORMED DURING EXTRUSION UNDER AIR, NEAR THE INFUSION CANNULA SITE. THE CAUSE WAS UNKNOWN. HEAVY LIQUID AND EXTRUSION WAS USED TO ATTEMPT TO FLATTEN RETINA. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: Retinal Detachment

  MAUDE report 22813927 ↗
• MalfunctionJul 15, 2025Failure to Cut; Failure to Cut

  A NURSE REPORTED THAT THE PROBE STOPPED CUTTING WHILE IN THE PATIENT¿S EYE DURING VITREORETINAL SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE ASPIRATION FUNCTION WAS NORMAL. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22506890 ↗
• MalfunctionFeb 18, 2025Suction Failure; Suction Failure

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE FLUIDICS MODULE DISPLAYED AN ERROR CODE, ASPIRATION COULD NOT FUNCTION, VALVED CANNULAS WERE LEAKING AND EYE WAS TOO SOFT WHICH WAS STABILIZED BY PERFLUROPROPANE (C3F8) AND A SYRINGE WITH THIRTY GAUGE NEEDLE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN ABOUT HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO CASSETTE INVOLVED IN REPORTED EVENT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 21400620 ↗
• MalfunctionFeb 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE FLUIDICS MODULE DISPLAYED AN ERROR CODE, ASPIRATION COULD NOT FUNCTION, VALVED CANNULAS WERE LEAKING AND EYE WAS TOO SOFT WHICH WAS STABILIZED BY PERFLUROPROPANE (C3F8) AND A SYRINGE WITH THIRTY GAUGE NEEDLE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN ABOUT HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO ENTRY SYSTEM INVOLVED IN REPORTED EVENT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 21392257 ↗