UNITY 00380650003393Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380650003393), received between Jul 25, 2025 and Sep 9, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Suction Problem

  A physician reported that aspiration was poor during cataract surgery (with intraocular lens implant). The surgery was successfully completed on same day by replacing it with another product. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693361 ↗
• InjuryAug 10, 2026Appropriate Device Problem Term/Code Not Available

  A customer reported that there was display of error code during cataract surgery (with intra ocular lens implantation) surgery in the right eye of a male elderly patient. The incident resulted in prolonged delay in the start and progression of the surgical procedures causing anxiety and discomfort in patient requiring supplemental sedation and oxygen therapy, as well as delaying their postoperative discharge. Although inpatient admission was not required; management was outpatient-based and the patient was prescribed with topical ophthalmic drops per standard post-cataract surgery protocol. There was no negative consequences on the patient and the patient was recovering.This report pertains to one of the two cassettes involved in reported events.

  Patient problems: Anxiety; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50194814 ↗
• MalfunctionMay 28, 2026Obstruction of Flow

  A HEALTH CARE PROFESSIONAL REPORTED THAT CASSETTE ASPIRATION LINE WAS BLOCKED DURING INTRAOCULAR LENS IMPLANTATION SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER PRIMING THE CASSETTE WITHOUT THE HANDPIECE, WHICH CLEARED THE ASPIRATION LINE AND RESTORED FUNCTIONALITY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25313384 ↗
• MalfunctionMar 10, 2026Suction Problem; Infusion or Flow Problem

  A NURSE REPORTED THAT PRIMING WAS DONE WITHOUT ISSUE AND COMPLETED PHACOEMULSIFICATION (PHACO) PART OF SURGERY, FOLLOWED BY IRRIGATION/ASPIRATION (I/A). SUBSEQUENTLY, AN ERROR MESSAGE INDICATING ¿FLUIDICS NOT OPERATIONAL¿ WAS DISPLAYED. AT THIS POINT, THERE WAS NO IRRIGATION OR ASPIRATION OR VACUUM OR PHACO AVAILABLE DURING CATARACT WITH INTRAOCULAR LENS IMPLANT SURGERY. CONNECTED LINES TO TEST COULD SEE FOOT PEDAL BEING DEPRESSED BUT NO FLUIDICS. THE HANDPIECE AND FLUID MANAGEMENT SYSTEM (FMS) WAS THEN REMOVED. THE SYSTEM WAS POWERED DOWN. THE SURGEON DID NOT REQUIRE I/A AGAIN TO COMPLETE THE CASE. AFTER REBOOTING THE SYSTEM, THE REMAINING OF THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT PERTAINS TO THE CASSETTE INVOLVED FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24554615 ↗
• MalfunctionMar 2, 2026Air/Gas in Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT TUBING COULD NOT PRIME AND THERE WERE MULTIPLE BUBBLES IN THE LINE AT AN UNKNOWN TIMING. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24480749 ↗
• MalfunctionJan 23, 2026Air/Gas in Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER PRIMING, BUBBLES WERE VISIBLE IN THE IRRIGATION LINE. THESE WERE REMOVED BY ACTIVATING IRRIGATION PRIOR TO CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE LINES WERE CLEAR BEFORE THE CASE BEGAN; HOWEVER, MIDWAY THROUGH SURGERY, DURING THE PHACOEMULSIFICATION STEPS, BUBBLES BECAME EVIDENT. THE SURGEON PAUSED TO REMOVE THE BUBBLES VIA ASPIRATION, AS THE VIEW WAS COMPLETELY OBSTRUCTED. THIS ISSUE WAS OBSERVED IN SIX SEPARATE CASES. THE PROCEDURE COMPLETION DETAILS HAVE NOT BEEN PROVIDED, BUT THERE WAS NO PATIENT IMPACT. THIS REPORT PERTAINS TO CASSETTE INVOLVED FOR THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159695 ↗
• MalfunctionDec 19, 2025Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT THE PRODUCTS FAILED TO ASPIRATE, SO THE SURGEON OPTED FOR ANOTHER MACHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23852177 ↗
• MalfunctionDec 19, 2025Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT THE PRODUCTS FAILED TO ASPIRATE, SO THE SURGEON OPTED FOR ANOTHER MACHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23852121 ↗
• MalfunctionNov 24, 2025Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent

  A CUSTOMER REPORTED THAT ERROR CODE DISPLAYED, TUBING FOLD WAS OBSERVED AND THERE WAS NO ULTRASOUND DURING SURGERY. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. REQUESTED ADDITIONAL INFORMATION NOT RECEIVED TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 23631822 ↗
• MalfunctionNov 24, 2025Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent

  A CUSTOMER REPORTED THAT ERROR CODE DISPLAYED, TUBING FOLD WAS OBSERVED AND THERE WAS NO ULTRASOUND DURING SURGERY. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. REQUESTED ADDITIONAL INFORMATION NOT RECEIVED TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 23630343 ↗
• MalfunctionOct 15, 2025Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE ASPIRATION WAS FLUCTUATING BY GOING UP AND DOWN DURING QUADRANT MODE OF CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE SURGERY WAS COMPLETED USING THE SAME PRODUCT WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT IMPACT. THIS REPORT PERTAINS TO THE CASSETTE INVOLVED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301039 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  A PHYSICIAN REPORTED THAT THE BALANCED TIP WAS BENT BEFORE CATARACT WITH INTRAOCULAR IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE TIP WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23297458 ↗
• 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 23278342 ↗
• MalfunctionSep 12, 2025Obstruction of Flow; Obstruction of Flow

  A CUSTOMER REPORTED THAT OPTHALMIC OPERATING CONSOLE DURING THE CATARACT SURGERY EXHIBITED A PROBLEM THAT PIECES OF NUCLEUS WOULD FALL OFF THE TIP DURING PHACOEMULSIFICATION VERY OFTEN AND FAINT BEEPING SOUND FROM THE SYSTEM. THE PATIENT HAD IRIS TO SHUTTER EACH TIME AND IRIS WAS MOVING A LOT MORE THAN USUAL DURING SURGERY. PROCEDURE WAS COMPLETED ON THE SAME DAY. THE CURRENT OUTCOME OF THE PATIENT CONDITION WAS UNKNOWN.

  Patient problems: Eye Injury; Intraocular Pressure Decreased

  MAUDE report 23039246 ↗
• MalfunctionSep 11, 2025Obstruction of Flow; Obstruction of Flow

  A CUSTOMER REPORTED THAT THE PIECES OF NUCLEUS WOULD FALL OFF THE TIP AND, IRIS TO SHUTTER, AND IRIS WAS MOVING A LOT DURING CATARACT WITH INTRAOCULAR LENS IMPLANT SURGERY. THERE WAS NO PATIENT IMPACT. THIS REPORT PERTAINS TO PHACOEMULSIFICATION TIP INVOLVED IN THIS REPORTED EVENT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 23023643 ↗
• MalfunctionSep 9, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A CUSTOMER REPORTED THAT OBSERVED MODERATE CHAMBER INSTABILITY DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT (IOL). THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT. THIS REPORT PERTAINS TO THE CASSETTE INVOLVED IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004460 ↗
• MalfunctionSep 5, 2025Suction Problem; Infusion or Flow Problem; Suction Problem; Infusion or Flow Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE LOST PHACOEMULSIFICATION POWER AND LOST IRRIGATION ALONG WITH ANTERIOR CHAMBER UNSTABLE DURING QUADRANT MODE OF INTRAOCULAR LENS IMPLANTATION SURGERY. REPRIMED AND TUNED THE HANDPIECE AND THEN WAS ABLE TO COMPLETE THE CASE NORMALLY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 22975586 ↗
• MalfunctionSep 3, 2025Air/Gas in Device; Air/Gas in Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT BUBBLES WERE SEEN AT ALL STEPS INCLUDING PHACO BUT MAINLY IRRIGATION ASPIRATION (I/A). THE SURGERY DETAILS AND PATIENT DETAILS WERE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22951167 ↗
• MalfunctionAug 28, 2025Air/Gas in Device; Air/Gas in Device

  A CUSTOMER REPORTED THAT THERE WAS A LITTLE BIT OF CHAMBER INSTABILITY BUT REALLY NOTICING CHAMPAGNE BUBBLES IN VISCOSE REMOVAL AT AN UNKNOWN TIMING. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CHAMBER WAS MUCH MORE STABLE AND COULD NOT EXPERIENCE A SINGLE CASE OF BUBBLES IN VISCO-REMOVAL. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. THIS REPORT PERTAINS TO THE CASSETTE INVOLVED IN REPORTED EVENT. ADDITIONAL INFORMATION REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 22913800 ↗
• MalfunctionAug 25, 2025Air/Gas in Device; Air/Gas in Device

  A CUSTOMER REPORTED THAT BUBBLES ARE APPEARED DURING CORTEX NOT VISCO REMOVAL SURGERY. THE SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 22881720 ↗
• MalfunctionAug 5, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS VACUUM BUT NO IRRIGATION DURING INTRAOCULAR LENS IMPLANTATION SURGERY. THE ANTERIOR CHAMBER WAS BRIEFLY COLLAPSED IN THE EYE. THE SURGERY WAS COMPLETED AFTER REPLACING THE FLUIDIC MANAGEMENT SYSTEM. THERE WAS NO REPORT OF PATIENT IMPACT.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 22712151 ↗
• MalfunctionJul 25, 2025Air/Gas in Device; Air/Gas in Device

  A CONSUMER REPORTED THAT THE FLUIDICS MANAGEMENT SYSTEM ISSUE MAY ATTRIBUTE TO BUBBLES IN THE EYE DURING INTRAOCULAR LENS INSERTION SURGERY. ALSO STATED THAT THE NEW SYSTEM IN USE, TROUBLE PASSING ONE STEP PRIME AND TUNE FOR CATARACT CASES. ALSO BUBBLES INTRODUCED INTO THE EYE DURING CORTEX AND VERY NOTICEABLY IN VISCOELASTIC MODE AFTER INTRAOCULAR LENS INSERTION. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607358 ↗
• MalfunctionJul 25, 2025Air/Gas in Device; Air/Gas in Device

  A CONSUMER REPORTED THAT THE FLUIDICS MANAGEMENT SYSTEM ISSUE MAY ATTRIBUTE TO BUBBLES IN THE EYE DURING INTRAOCULAR LENS INSERTION SURGERY. ALSO STATED THAT THE NEW SYSTEM IN USE, TROUBLE PASSING ONE STEP PRIME AND TUNE FOR CATARACT CASES. ALSO BUBBLES INTRODUCED INTO THE EYE DURING CORTEX AND VERY NOTICEABLY IN VISCOELASTIC MODE AFTER INTRAOCULAR LENS INSERTION. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607356 ↗