UNITY 00380650003829Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380650003829), received between Aug 26, 2025 and Sep 30, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Air/Gas in Device

  A physician reported that air flowed from air line when infusion was clamped during surgery. The procedure type was unknown. The surgery was completed on the same day by replacing the product with another one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943434 ↗
• MalfunctionMar 18, 2026Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER KEPT MALFUNCTIONING WHILE CUTTING DURING THE VITRECTOMY SURGERY. THE CUT RATE WAS 7500 AND NO SYSTEM MESSAGE WAS DISPLAYED. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629592 ↗
• MalfunctionFeb 23, 2026Improper Flow or Infusion

  A PHYSICIAN REPORTED THAT AIR REPLACEMENT WAS NOT POSSIBLE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411525 ↗
• MalfunctionJan 13, 2026Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT WHEN USING BACKFLUSH, ASPIRATION WAS NOT POSSIBLE AND ERROR CODE DISPLAYED DURING THE CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH THE SAME PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050716 ↗
• InjuryDec 5, 2025Infusion or Flow Problem; Infusion or Flow Problem

  A PHYSICIAN REPORTED THAT POOR IRRIGATION LED TO INCOMPLETE FORMATION OF THE ANTERIOR CHAMBER, RESULTING IN POSTERIOR CAPSULE RUPTURE, CORNEAL ENDOTHELIAL DAMAGE (DECREASE IN CORNEAL ENDOTHELIAL CELLS) AND HAD CHAMBER SHALLOWING IN CHOP MODE DURING THE CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF PATIENT SYMPTOMS WERE CONTINUING.

  Patient problems: Capsular Bag Tear; Corneal Endothelial Cell Loss; Intraocular Pressure Decreased

  MAUDE report 23725172 ↗
• MalfunctionOct 24, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT AFTER IOP (INTRAOCULAR PRESSURE) WAS RAISED, THERE WAS NO ASPIRATION AND ULTRASOUND WERE PRESENT DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, BUT IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378210 ↗
• MalfunctionOct 24, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT AFTER IOP (INTRAOCULAR PRESSURE) WAS RAISED, THERE WAS NO ASPIRATION AND ULTRASOUND WERE PRESENT DURING CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, BUT IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378204 ↗
• MalfunctionAug 26, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT THE ADVISORY WAS DISPLAYED SAYING THE VENT CHAMBER WAS EMPTY AND LOUD NOISE WAS GENERATED DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896337 ↗