Malyugin Ring System 2.0, 6.25mmRecalls & reported problems across all models
Microsurgical Technology, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 83
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 2 models of Malyugin Ring System 2.0, 6.25mm by Microsurgical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 83 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2023 and Mar 31, 2026 — classified as 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Malyugin Ring System 2.0, 6.25mm problems
Device problems
- Difficult to Fold, Unfold or Collapse76
- Component Incompatible2
- Difficult to Insert1
- Ejection Problem1
- Material Fragmentation1
- Mechanical Problem1
- No Apparent Adverse Event1
- Retraction Problem1
Patient problems
- Insufficient Information79
- Eye Injury3
- No Clinical Signs, Symptoms or Conditions2
Malyugin Ring System 2.0, 6.25mm models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Malyugin Ring System 2.0, 6.25mm MAL-1001-1Clip, Iris Retractor81 reports
- Malyugin Ring System 2.0, 6.25mm MAL-1001Clip, Iris Retractor2 reports
Recent Malyugin Ring System 2.0, 6.25mm adverse event reports
The 15 most recent reports across all models, 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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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