Malyugin Ring System 6.25mm MAL-0001-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00844685000029), received between Jan 7, 2022 and Mar 31, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Difficult to Fold, Unfold or Collapse

  1 ITEM WAS BENT AT TIP, THE OTHER MALFUNCTIONED UPON DEPLOY. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24746132 ↗
• MalfunctionMar 10, 2026Difficult to Fold, Unfold or Collapse

  DEFECTIVE MALYUGIN RING AT TIME OF DEPLOYMENT. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24565244 ↗
• MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse

  MALYUGIN RING BENT UPON INSERTION. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24548130 ↗
• MalfunctionFeb 17, 2026Difficult to Fold, Unfold or Collapse

  DEFECTIVE MALYUGIN RING. IT WAS ALL BENT UP AND CRAZY LOOKING WHEN IT CAME OUT OF THE INJECTOR. THERE WAS NO HARM CAUSED BY THE DEFECTIVE PRODUCT. WE JUST OPENED A DIFFERENT ONE.

  Patient problems: Insufficient Information

  MAUDE report 24369741 ↗
• MalfunctionDec 1, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  WE HAD A DEVICE THAT DURING THE CASE THE RING FELL OFF.

  Patient problems: Insufficient Information

  MAUDE report 23689592 ↗
• MalfunctionNov 6, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  ONCE IT UNFOLDED IN THE EYE THERE WAS NO GIVE OR BEND ON ONE OF THE SIDES. HE WAS UNABLE TO BEND IT TO PLACE IT INTO THE IRIS. REMOVED AND NEW RING USED.

  Patient problems: Insufficient Information

  MAUDE report 23492065 ↗
• MalfunctionOct 31, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  DEVICE WAS INSERTED INTO EYE. RING WAS TWISTED WHEN FIRST ATTEMPTED TO DEPLOY. RING AND DEVICE WERE REMOVED WHEN DEFECT WAS NOTED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438830 ↗
• MalfunctionAug 21, 2024Retraction Problem; Device Dislodged or Dislocated; Retraction Problem; Device Dislodged or Dislocated

  DURING CATARACT SURGERY THE MALYUGIN RING'S SUBINCISIONAL RING DISENGAGED AND WAS CAUGHT BEHIND THE IOL. THE SURGEON WAS FORCED TO CUT THE RING OUT OF THE EYE LEAVING A SMALL PORTION OF IT IN THE CAPSULOR BAG WITH THE IOL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20021514 ↗
• InjuryJan 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE DISTRIBUTOR REPORTED THAT THE SURGEON HAD DIFFICULTY REMOVING THE RING FROM THE AND THERE WAS SUBSEQUENT IRIS DAMAGE.

  Patient problems: Eye Injury

  MAUDE report 13198755 ↗