UNITY 00380650002976Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380650002976), received between Jul 18, 2025 and Sep 14, 2026 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Air/Gas in Device

  A non-healthcare professional reported that bubbles during Quad, Cortex, and Visco removal. The surgeon stated that these bubbles are affecting visibility during surgery. The procedure type was unknown. The issue persisted despite adjustments to the intraocular pressure ramp and incision size/tip sleeve settings. (b)(4). Although the issue was no longer present in every case, the surgeon continued to report impaired visualization. The surgery completion details were unknown. There was no information about the patient impact. This complaint pertains to the ophthalmic system involved in the reported events and represents two of the three reports received from the same facility.

  Patient problems: Insufficient Information

  MAUDE report 50756248 ↗
• MalfunctionSep 14, 2026Air/Gas in Device

  A non-healthcare professional reported that bubbles during Quad, Cortex, and Visco removal. The surgeon stated that these bubbles are affecting visibility during surgery. The procedure type was unknown. The issue persisted despite adjustments to the intraocular pressure ramp and incision size/tip sleeve settings. These changes reduced the frequency of the bubbles; however, bubbles during cortex and/or viscoelastic removal continued to occur in approximately 50 percent of cases, and bubbles during quadrant removal was observed in 5 cases. Although the issue was no longer present in every case, the surgeon continued to report impaired visualization. The surgery completion details were unknown. There was no information about the patient impact. This complaint pertains to the ophthalmic system involved in the reported events and represents three of the three reports received from the same facility.

  Patient problems: Insufficient Information

  MAUDE report 50755655 ↗
• MalfunctionSep 11, 2026Air/Gas in Device

  Patient problems: Insufficient Information

  MAUDE report 50737740 ↗
• MalfunctionSep 7, 2026Pressure Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50649368 ↗
• MalfunctionSep 2, 2026Pressure Problem

  A healthcare professional reported that an ophthalmic console exhibited chamber instability following a software update. The surgery was completed during the same session. Information regarding the procedure details and any patient impact was not provided. Additional information has been requested; however, it is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50567769 ↗
• MalfunctionAug 7, 2026Suction Problem; Noise, Audible

  Patient problems: Insufficient Information

  MAUDE report 50172776 ↗
• MalfunctionJul 31, 2026Failure to Cut; Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50096069 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT PATIENT EXPERIENCED DURING NUCLEUS REMOVAL ANTERIOR CHAMBER COLLAPSE DUE TO FLUIDICS IMBALANCE AND RESULTED IN POSTERIOR CAPSULE RUPTURE. THE CURRENT CONDITION OF THE PATIENT AND EVENT OUTCOME WAS UNKNOWN. THE SURGERY WAS MANAGED WITH ANTERIOR VITRECTOMY AND REMOVAL OF VITREOUS FROM THE ANTERIOR CHAMBER AND COMPLETED SUCCESSFULLY.

  Patient problems: Capsular Bag Tear; Intraocular Pressure Decreased

  MAUDE report 25253579 ↗
• MalfunctionApr 20, 2026No Device Output; Improper Flow or Infusion; Priming Problem

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION IN THE RIGHT EYE, THE OPHTHALMIC SYSTEM EXHIBITED NO IRRIGATION. WHEN THE SURGEON ATTEMPTED TO USE THE SYSTEM IN PHACOEMULSIFICATION MODE, IT WAS NOT FUNCTIONING. THE ISSUE WAS NOT RESOLVED EVEN AFTER REPRIMING FOUR TIMES. THE SURGERY WAS COMPLETED ON THE SAME DAY USING AN ALTERNATIVE SYSTEM, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933768 ↗
• MalfunctionApr 15, 2026Accessory Incompatible; No Device Output; Improper Flow or Infusion; Unexpected Shutdown

  A CUSTOMER REPORTED THAT THE OPHTHALMIC SYSTEM SHUT DOWN DURING PHACOEMULSIFICATION SURGERY. THE SYSTEM EXHIBITED A COMPLETE LOSS OF PHACOEMULSIFICATION AND FLUIDICS FUNCTIONALITY. THE FOOT PEDAL BECAME NON RESPONSIVE, AND THE GREEN INDICATOR LIGHT ON THE PORT TURNED OFF. THE SYSTEM WAS REBOOTED AND THE SYSTEM MESSAGE WAS ENCOUNTERED. FOLLOWING THE REBOOT AND RE PRIMING/TUNING, THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24881591 ↗
• MalfunctionMar 30, 2026Improper Flow or Infusion

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC SYSTEM EXHIBITED SURGE DURING CHOP AND QUADRANT REMOVAL MODE OF SURGERY EVE AFTER ADJUSTING THE PARAMETERS. DURING THE IRRIGATION AND ASPIRATION MODE OF THE SURGERY THE IRRIGATION FLOW INTERMITTENTLY STOPS WHILE PERFORMING HYDRO-IMPLANTATION. THE SYSTEM ALSO EXHIBITED AN ISSUE WITH CHAMBER STABILITY THROUGHOUT THE SURGERY. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24723774 ↗
• MalfunctionMar 26, 2026Improper Flow or Infusion

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, THE OPHTHALMIC CONSOLE DISPLAYED A HIGH IRRIGATION SYSTEM MESSAGE, AND A NOTIFICATION APPEARED ON THE SCREEN INDICATING THAT ALL FLUIDICS WERE SUSPENDED, WITH NO IRRIGATION, NO ASPIRATION, AND A BREAK IN OCCLUSION. THIS ISSUE WAS TRIGGERED BY WOUND LEAKAGE IN THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND INFORMATION REGARDING PATIENT IMPACT HAS NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24696322 ↗
• InjuryMar 6, 2026Suction Problem

  A NURSE REPORTED THAT PATIENT EXPERIENCED WOUND BURN, CORNEAL INJURY AND CORNEAL OPACITY STITCHES REQUIRED. DROP HAS BEEN PRESCRIBED POST SURGERY. OPHTHALMIC SYSTEM AND HANDPIECE EXHIBITED NO ASPIRATION DURING THE SCULP MODE OPHTHALMIC SYSTEM AND ALSO DISPLAYED SYSTEM MESSAGE.

  Patient problems: Corneal Scar; Eye Burn

  MAUDE report 24530730 ↗
• MalfunctionFeb 20, 2026Improper Flow or Infusion

  A CUSTOMER REPORTED THAT DURING A SURGERY AN OPHTHALMIC SYSTEM EXHIBITED CHAMBER INSTABILITY OCCASIONALLY. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24399574 ↗
• MalfunctionFeb 20, 2026Improper Flow or Infusion

  A CUSTOMER REPORTED THAT AN OPHTHALMIC SYSTEM HAD UNSTABLE CHAMBER. DETAILS OF PROCEDURE AND PATIENT IMPACT WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24398802 ↗
• MalfunctionFeb 11, 2026Pressure Problem

  A PHYSICIAN REPORTED THAT DURING ANTERIOR VITRECTOMY SURGERY AN OPHTHALMIC OPERATING SYSTEM HAD TOO MUCH FLUCTUATIONS IN THE CHAMBER. THE SURGERY WAS COMPLETED ON THE SAME DAY BY CHANGING THE SYSTEM FOR EMERGENCY BASIS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312614 ↗
• MalfunctionJan 12, 2026No Device Output; Suction Problem

  A CUSTOMER REPORTED THAT DURING PHACOEMULSIFICATION MODE OF SURGERY AN OPHTHALMIC SYSTEM'S PHACO AND ASPIRATION COMPLETELY STOPPED. THE SYSTEM WAS RE-BOOTED AND RE-PRIMED TO COMPLETE THE CASE. DETAILS RELATED TO PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 24035665 ↗
• MalfunctionDec 19, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING PHACOEMULSIFICATION STEPS THE SURGEON FELT ANTERIOR CHAMBER WAS UNSTABLE WHEN INTELLIGENT SENTRY WAS SET TO MAXIMUM IN THE ADVANCED TAB. WHEN THE SETTING WAS CHANGED TO HIGH OR MEDIUM, SURGEON FELT ANTERIOR CHAMBER STABILITY WAS IMPROVED. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23848636 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT BEFORE THE USE OF OPHTHALMIC SYSTEM THE PATIENT EXPERIENCED IRIS PROLAPSE OUT OF MAIN INCISION. THE IRIS WAS REPOSITIONED MANUALLY, WITH VISCOELASTIC. THE SURGERY CONTINUED WITHOUT FURTHER ISSUE. THE SURGEON DID COMMENT THAT THE IRIS WAS EXCEPTIONALLY LOOSE AS FIRST FOUND. THE PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE. THIS COMPLAINT IS PERTAINING THE TWO OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.

  Patient problems: Prolapse

  MAUDE report 22540392 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT DURING FEMTOSECOND LASER ASSISTED CATARACT SURGERY IN HYDRO DISSECTION STEP THE PATIENT HAS EXPERIENCED CAPSULAR TEAR AT THE ORIGINAL RHEXIS EDGE. THE SURGERY WAS PROCEEDED WITH A THREE PIECE INTRAOCULAR LENS PLACEMENT. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT IS PERTAINING THE ONE OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.

  Patient problems: Capsular Bag Tear

  MAUDE report 22539945 ↗