Malyugin Ring System 2.0, 6.25mm MAL-1001-1Recalls & reported problems
Microsurgical Technology, Inc. · Class 1
All models of Malyugin Ring System 2.0, 6.25mm (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Microsurgical Technology Malyugin Ring is an iris retractor used to hold the pupil open during eye surgery. Reports mostly describe the ring twisting, kinking or failing to unfold and deploy correctly from its injector. There are 81 reports that name its identifier, with no deaths and 2 injuries. No recalls name this device, and reports rose from
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 81
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00844685006120), received between Aug 15, 2025 and Mar 31, 2026 — classified as 2 injuries, 79 malfunctions.
The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (76 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.
Reports received per month
Most reported problems
Device problems
- Difficult to Fold, Unfold or Collapse76
- Component Incompatible2
- Difficult to Insert1
- Ejection Problem1
- Retraction Problem1
Patient problems
- Insufficient Information79
- Eye Injury2
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Difficult to Fold, Unfold or Collapse
NEWER RING VERSION WORKS POORLY AND TWISTS ON INSERTION AND HAS FAILED ON 3 CONSECUTIVE PATIENTS. NOT PATIENT INJURY, BUT REQUIRED USE OF IRIS HOOKS WHICH ADDED TO SURGICAL CENTER COST. IRIS HOOKS REQUIRED ON 3 PATIENTS (ONE PATIENT USED TWO RINGS, BOTH FAILED TO WORK).
Patient problems: Insufficient Information
MAUDE report 24749701 ↗MalfunctionMar 31, 2026Difficult to Fold, Unfold or Collapse
RING INJECTED CROOKED. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24748348 ↗MalfunctionMar 31, 2026Difficult to Fold, Unfold or Collapse
DID NOT DEPLOYED CORRECTLY AND RING DEFECTED. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24747867 ↗MalfunctionMar 31, 2026Difficult to Fold, Unfold or Collapse
ISSUES WITH THE RING BEING "KINKED" PER THE SURGEON, AND NOT ABLE TO BE INSERTED PROPERLY. IT IS TWO OF THEM. ALL HAVE THE SAME LOT NUMBER.
Patient problems: Insufficient Information
MAUDE report 24746576 ↗MalfunctionMar 30, 2026Difficult to Fold, Unfold or Collapse
DR. (B)(6) ATTEMPTED TO USE TWO DIFFERENT MALYUGIN RINGS FROM THE SAME BOX (INFORMATION ABOVE). HE WAS UNSUCCESSFUL AT DELIVERING THE RING AS IT WAS TWISTED IN THE DELIVERY. THE FRONT RING WOULD DEPLOY BUT THE SECOND TWO ARE TWISTED TOGETHER. HE ATTEMPTED TO UNTWIST IT WITH A SECOND INSTRUMENT BUT WAS UNSUCCESSFUL. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24737209 ↗MalfunctionMar 23, 2026Difficult to Fold, Unfold or Collapse
MALYUGIN RING DID NOT RETRACK CORRECTLY TO USE FOR IMPLANT. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24670054 ↗MalfunctionMar 23, 2026Difficult to Fold, Unfold or Collapse
DEFECTIVE, RETRACTED INCORRECTLY. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24669939 ↗MalfunctionMar 23, 2026Difficult to Fold, Unfold or Collapse
MALYUGIN RING MALFUNCTION, NOT ABLE TO FIRE CORRECTLY. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24669677 ↗MalfunctionMar 23, 2026Difficult to Fold, Unfold or Collapse
THE RING WOULD GET TANGLED ON THE HOOK WHEN TRYING TO DEPLOY IT. DOCTOR TRIED 3 TIMES AND ALL OF THEM WERE DEFECTIVE. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24669624 ↗MalfunctionMar 20, 2026Difficult to Fold, Unfold or Collapse
THE DOCTOR HAD TROUBLE INSERTING 2 OUT OF ONE BOX AND WANTED TO RETURN ALL BOXES WITH THAT LOT NUMBER. ONE DID NOT ADVANCE, ONE CAME OUT OF THE INJECTOR INCORRECTLY, TWO LEADING LOOP WILL COME OUT BUT THE OTHER LOOPS ARE WRAPPED AROUND EACH OTHER. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24656343 ↗MalfunctionMar 17, 2026Difficult to Fold, Unfold or Collapse
WOULD NOT DEPLOY. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24623794 ↗MalfunctionMar 17, 2026Difficult to Fold, Unfold or Collapse
UPON DEPLOYMENT INTO PATIENT'S EYE, THE RING GOT CAUGHT, "KINKED", CRIMPED IN THE INSERTION DEVICE, RESULTING IN INCOMPLETE DEPLOYMENT. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24622283 ↗MalfunctionMar 16, 2026Difficult to Fold, Unfold or Collapse
RING CAME OUT TWISTED UPON INJECTION. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24607192 ↗MalfunctionMar 16, 2026Difficult to Fold, Unfold or Collapse
PER SURGEON, WAS BENT WHEN EJECTED AND WOULD NOT FUNCTION PROPERLY. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24607172 ↗MalfunctionMar 16, 2026Difficult to Fold, Unfold or Collapse
THE DEVICE COILED AND DIDN'T EXPAND PROPERLY. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24607146 ↗MalfunctionMar 13, 2026Difficult to Fold, Unfold or Collapse
WHEN MALYUGIN RING IS DEPLOYED, RING DID NOT COME OUT. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24599452 ↗MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse
PRODUCT WOULD NOT EXPAND NOR ADVANCE, SUTURE COMES OUT MANGLED. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24553243 ↗MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse
ONE OF THE RINGS WAS FLAT AND NOT ABLE TO BE MANIPULATED BY THE MD. RING HAD PATIENT CONTACT BUT WAS REMOVED AND PROCEDURE WAS SUCCESSFULLY ABLE TO BE COMPLETED.NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 24553163 ↗MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse
PRODUCT WOULD NOT EXPAND NOR ADVANCE, SUTURE COMES OUT MANGLED. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24552704 ↗MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse
RINGS FAILED TO EXPAND FULLY. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24552352 ↗MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse
PRODUCT WOULD NOT EXPAND NOR ADVANCE, SUTURE COMES OUT MANGLED. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24552193 ↗MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse
RETRACT MALYUGIN RING VERY SLOWLY AND NOTICE IT PULLING TO THE LEFT THE EYELETS WERE NOT OVERLAPPING EACH OTHER, SO I STOP AND ASK FOR A NEW ONE. THE SECOND ONE DID NOT ADVANCE PROPERLY IN THE EYE. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24552018 ↗MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse
RECENTLY HAD TWO DEFECTIVE MALYUGIN RINGS THAT I NEED TO GET REPLACED. THE TWO DEFECTIVE LOT NUMBERS INCLUDE. LUCKILY NO PATIENT INJURY, BUT BOTH HAPPENED UPON DEPLOYMENT INTO THE EYE.
Patient problems: Insufficient Information
MAUDE report 24547108 ↗MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse
RING DID NOT FULLY RETRACT INTO INSERTER AND DEPLOYED BENT/TWISTED, UNUSABLE. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24547054 ↗MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse
DEVICE DOES NOT DEPLOY CORRECTLY. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24546913 ↗
Other Clip, Iris Retractor devices
- Malyugin Ring System 2.0, 7.0mm MAL-1002-1Microsurgical Technology, Inc. · Clip, Iris Retractor29 reports
- Malyugin Ring System 6.25mm MAL-0001-1Microsurgical Technology, Inc. · Clip, Iris Retractor9 reports
- Malyugin Ring System 7.0mm MAL-0002-1Microsurgical Technology, Inc. · Clip, Iris Retractor7 reports
- Alcon Grieshaber 611.74Alcon Laboratories, Inc. · Clip, iris retractor4 reports
- Malyugin Ring System 7.0mm MAL-0002Microsurgical Technology, Inc. · Clip, Iris Retractor2 reports
- Malyugin Ring System 2.0, 6.25mm MAL-1001Microsurgical Technology, Inc. · Clip, Iris Retractor2 reports
- Alcon Grieshaber 611.75Alcon Laboratories, Inc. · Clip, iris retractor1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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