UNITY 00380650003409Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380650003409), received between Sep 2, 2025 and Sep 29, 2026 — classified as 7 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Suction Problem

  A physician reported that the aspiration could not be performed during irrigation and aspiration mode of the surgery. The procedure type was unknown. The surgery was completed on same day after replacing the product with another one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934511 ↗
• MalfunctionSep 28, 2026Suction Problem

  A physician reported that aspiration could not be performed at irrigation and aspiration (IA) mode during surgery. The surgery type was unknown. The surgery was completed on same day after replacing the same product with another one. There was patient contact with suspect product but no impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916284 ↗
• MalfunctionJan 6, 2026Suction Problem

  A PHYSICIAN REPORTED THAT THERE WAS NO ASPIRATION DURING ULTRASOUND OF CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986386 ↗
• MalfunctionNov 24, 2025Improper Flow or Infusion; Appropriate Device Problem Term/Code Not Available; Improper Flow or Infusion; Appropriate Device Problem Term/Code Not Available

  THE PHYSICIAN REPORTED THAT THE CASSETTE DISPLAYED SOME RESETTABLE ADVISORIES AND THERE WAS NO INFUSION GOING INTO THE EYE LEADING TO ANTERIOR CHAMBER INSTABILITY DURING SCULPT MODE OF VITREO-RETINAL SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE CASSETTE WITH ANOTHER ONE AS WELL CHANGING CHANGING THE EQUIPMENT. THERE WAS PATIENT CONTACT BUT NO IMPACT TO THE PATIENT. THIS REPORT PERTAINS TO CASSETTE INVOLVED IN REPORTED EVENTS.

  Patient problems: Intraocular Pressure Decreased

  MAUDE report 23633881 ↗
• MalfunctionOct 21, 2025Failure to Prime; Failure to Read Input Signal; Infusion or Flow Problem; Failure to Prime; Failure to Read Input Signal; Infusion or Flow Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT NO IRRIGATION, MACHINE WOULD NOT RECOGNIZE THE CASSETTE AND UNABLE TO PRIME DURING CORTEX REMOVAL SURGERY. THE SURGERY DETAILS AND PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23349142 ↗
• 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 22951172 ↗
• MalfunctionSep 2, 2025Suction Problem; Infusion or Flow Problem; Appropriate Device Problem Term/Code Not Available; Suction Problem; Infusion or Flow Problem; Appropriate Device Problem Term/Code Not Available

  A CUSTOMER REPORTED THAT CASSETTE AND HANDPIECE PASSED PRIME WHEN STARTED TO OPERATE IN CHOP MODE AN ERROR MESSAGE APPEARED AND NO FLUIDICS, NO VACUUM, NO PHACO WERE AVAILABLE. THE SURGERY WAS COMPLETED BY CHANGING THE PRODUCT. NO PATIENT IMPACT WAS REPORTED. THIS REPORT PERTAINS TO CASSETTE INVOLVED IN THIS REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22932638 ↗