Malyugin Ring System 7.0mm MAL-0002-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844685000043), received between Sep 14, 2020 and Mar 30, 2026 — classified as 3 injuries, 4 malfunctions.

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

• MalfunctionMar 30, 2026Difficult to Fold, Unfold or Collapse

  IT WASN'T RETRACTING OR ADVANCING PROPERLY. IT HAD PATIENT CONTACT. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24737078 ↗
• MalfunctionMar 3, 2026Difficult to Fold, Unfold or Collapse

  RINGS WOULD NOT PROPERLY EXPAND WHEN ADVANCING. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24503260 ↗
• MalfunctionFeb 18, 2026Difficult to Fold, Unfold or Collapse

  THE HOOK WAS MESSED UP AND DIDN'T RELEASE OR HOOK RIGHT. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24384860 ↗
• MalfunctionFeb 18, 2026Difficult to Fold, Unfold or Collapse

  OUT OF THE 6 MALYUGIN RINGS, 2 HAD ISSUES. ONE HAD NO RING AT ALL IN IT, AND THE OTHER WHEN ENGAGED WOULD TWIST, AND THE SURGEON COULD NOT MANIPULATE IT TO ALIGN PROPERLY. THE SURGEON DR. (B)(6) IS VERY FAMILIAR AND COMPETENT IN USING THIS PRODUCT.THERE WAS NO PATIENT INJURY INVOLVED.

  Patient problems: Insufficient Information

  MAUDE report 24384185 ↗
• InjurySep 18, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  YESTERDAY DR. (B)(6) USED THE 7.00MM RING AND SHE CLAIMED ONE OF THE SPRINGS IS DEFECTIVE. SHE STATED THAT THE DEFECTIVE SPRING TORN THE IRIS. FOLLOW UP INFO FROM THE DOCTOR: IT WAS PHACO SURGERY. THE IRIS WAS INCARCERATED INTO THE RINGLET AND REQUIRED MANIPULATION WITH A SINSKY AND KUGLEN TO FREE IT. ON INSPECTION AFTER THE CASE, THE RINGLET WAS FOUND TO HAVE SIGNIFICANT NARROWING AND AN IRREGULARITY/BURR WITHIN THE RINGLET. I TAMPONADE THE HEME AND PRESSURIZED THE EYE, WHICH FORTUNATELY WAS ENOUGH TO CONTROL THE BLEEDING. IT APPEARED TO RESULT IN A SMALL 1 CLOCK HOUR IRIDODIALYSIS, BUT HE IS NOT COMPLAINING OF LIGHT SENSITIVITY AT THIS POINT, SO I AM OBSERVING HIM FOR NOW.

  Patient problems: Eye Injury

  MAUDE report 23084970 ↗
• InjuryDec 18, 2020Physical Resistance/Sticking

  THE FACILITY REPORTED THAT THE MALYUGIN RING STUCK ON THE IRIS AND CAUSED BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11034613 ↗
• InjurySep 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  UPON REMOVAL OF THE MALYUGIN RING THERE WAS AN IRIS TEAR AND SOME BLEEDING OCCURRED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10532820 ↗