Malyugin Ring System 2.0, 7.0mm MAL-1002-1Recalls & reported problems
Microsurgical Technology, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Microsurgical Technology Malyugin Ring is a small flexible iris ring used to hold the eye open during cataract surgery. The 29 reports mostly describe the ring failing to fold, unfold or open properly — arms locking together, loops twisting or tangling, and kinks — so surgeons had to discard it and open another one. One report describes a tear of the eye's capsule, with 1 injury and no deaths. Reports rose sharply, from 2 to 27 in the past 12 months. No recalls name this device.
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
- 29
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00844685006137), received between Oct 15, 2025 and Apr 14, 2026 — classified as 1 injury, 28 malfunctions.
The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (29 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 Collapse29
Patient problems
- Insufficient Information27
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2026Difficult to Fold, Unfold or Collapse
ARMS LOCK ONTO EACH OTHER DURING LOADING AND DON'T DEPLOY. ONE PATIENT CAPSULE TEAR. SUCCESSFUL SURGERY BUT TURNED COMPLEX CHANGED TECHNIQUE.
Patient problems: Capsular Bag Tear
MAUDE report 24879617 ↗MalfunctionApr 7, 2026Difficult to Fold, Unfold or Collapse
A DEFECTIVE RING DURING DEPLOYING INTO PATIENT'S EYE. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24801379 ↗MalfunctionMar 31, 2026Difficult to Fold, Unfold or Collapse
RING TANGLED BEYOND USE WHEN DEPLOYED FROM DEVICE. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24748839 ↗MalfunctionMar 31, 2026Difficult to Fold, Unfold or Collapse
THE CUSTOMER FILED A MEDSUN REPORT (B)(4)TO FDA, THE REPORT STATES: THE MALYUGIN RING WAS OPENED FOR USE. HOWEVER, THE SURGEON NOTICED THE RING WAS NOT CORRECTLY ANGLED/DEFECTIVE WHEN DEPLOYED FOR USE. ANOTHER MALYUGIN RING WAS OPENED AND THE SURGEON NOTICED THE SAME ISSUE. PER THE TEAM, MATERIAL OF THE RING WAS CHANGED IN 2.0 VERSION. NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 24746020 ↗MalfunctionMar 20, 2026Difficult to Fold, Unfold or Collapse
SEVERAL OF THE MALYUGIN RINGS FROM THE LOT NUMBERS ABOVE DID NOT DEPLOY CORRECTLY DURING SURGERY. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24656329 ↗MalfunctionMar 16, 2026Difficult to Fold, Unfold or Collapse
RING WOULD NOT DEPLOY PROPERLY. RING WOULD NOT RETRACT PROPERLY. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24613221 ↗MalfunctionMar 9, 2026Difficult to Fold, Unfold or Collapse
THE LOOPS SEEMED TO BE INTERTWINED AND COULD NOT BE USED. THE RING WAS THEN TAKEN OUT AND ANOTHER RING HAD TO BE OPENED. THIS RING DID HAVE PATIENT CONTACT. NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 24553021 ↗MalfunctionMar 3, 2026Difficult to Fold, Unfold or Collapse
DID NOT EXPAND PROPERLY; HAD A KINK. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24503278 ↗MalfunctionFeb 23, 2026Difficult to Fold, Unfold or Collapse
DR. (B)(6) HAD A 7.0 RING (LOT# 212408) IN WHICH HE SAID THE "PLUNGER OVERRODE THE RING." ANOTHER FAULTY RING TODAY (DR. (B)(6), LOT# 214994, 6.25). SHE STATES IT WAS "STUCK TOGETHER". THERE WAS BRIEF PATIENT CONTACT. NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 24421402 ↗MalfunctionFeb 18, 2026Difficult to Fold, Unfold or Collapse
IN THE PAST COUPLE OF MONTHS, OUR DOCTOR HAS BEEN HAVING ISSUES WITH MAL-1002-1 MISFIRING WHEN INSERTED INTO THE EYE FOR CATARACT SURGERIES. TWO MORE OF MAL-1002-1 THAT MISFIRED. THERE WAS NO HARM TO ANY PATIENT.
Patient problems: Insufficient Information
MAUDE report 24385126 ↗MalfunctionFeb 18, 2026Difficult to Fold, Unfold or Collapse
SCROLLS COMING OUT SIDEWAYS AND MALFORMED ONE NOT RETRACTING. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24384773 ↗MalfunctionFeb 17, 2026Difficult to Fold, Unfold or Collapse
MALYUGIN RING RETRACTED WITH NO ISSUE INTO INJECTOR, BUT CAME OUT TWISTED WHEN INSERTED INTO THE EYE. NO PATIENT INJURY,
Patient problems: Insufficient Information
MAUDE report 24370310 ↗MalfunctionFeb 17, 2026Difficult to Fold, Unfold or Collapse
MALYUGIN RINGS THAT WERE DEFECTIVE AND DID NOT OPEN PROPERLY UPON INSERTION. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24369660 ↗MalfunctionFeb 2, 2026Difficult to Fold, Unfold or Collapse
WOULD NOT ADVANCE INTO PATIENTS EYE. INSTRUMENT WAS DISPOSED OF. NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 24240581 ↗MalfunctionFeb 2, 2026Difficult to Fold, Unfold or Collapse
HE DEVICE DEPLOYED BUT THEN CURLED UP. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24231359 ↗MalfunctionJan 15, 2026Difficult to Fold, Unfold or Collapse
DEFECTIVE GEOMETRIC CONFIGURATION OF RING ON DEPLOYMENT, RESULTING IN NON-FUNCTIONAL DEVICE. NO PATIENT INJURY. MULTIPLE HAVE SEEN 10-20 TIMES OVER PAST MANY MONTHS IN 2025. LATEST 12/18/25.
Patient problems: Insufficient Information
MAUDE report 24090278 ↗MalfunctionJan 15, 2026Difficult to Fold, Unfold or Collapse
RINGS DO NOT RETRACT WELL AND WHEN THE SURGEON TRIES TO PLACE THE RING, IT EITHER GETS TANGLED OR DOES NOT OPENED CORRECTLY. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24090224 ↗MalfunctionDec 31, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
BOTH WOULD NOT DEPLOY CORRECTLY . HAD [?]PT CONTACT BUT NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 23937092 ↗MalfunctionDec 29, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
THE RING MISSHAPEN UPON LEAVING INJECTOR. NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 23919123 ↗MalfunctionDec 24, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
DR (B)(6) TRIED TO USE THREE DIFFERENT M RINGS TODAY AND THE RINGS STUCK TOGETHER. THE LOT NUMBER IS 212110 I WOULD LIKE THE WHOLE BOX REPLACED PLEASE. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 23889289 ↗MalfunctionDec 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
MALYUGIN RING DID NOT EXIT CARTRIDGE/DEVICE CORRECTLY. PATIENT CONTACT NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 23830335 ↗MalfunctionDec 9, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
I HAVE A MALYUGIN RING (MAL-1002-1) THAT CAME OUT OF THE INSERTER DEFORMED. NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 23764744 ↗MalfunctionDec 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
OPENED THE MALYUGIN RING TO THE SURGICAL FIELD AND IT WOULD NOT LATCH. NO PATIENT INJURY REPORTED.
Patient problems: Insufficient Information
MAUDE report 23723657 ↗MalfunctionDec 4, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
THE FIRST WOULD NOT OPEN UP PROPERLY AND WAS UNSHAPED SO THAT IT COULD NOT ATTACH TO IRIS. - PATIENT CONTACT. NO INJURY THE 2ND ONE OF THE RINGS WAS BENT AND WOULD NOT UNFURL. NOTICED BEFORE ENTERING PATIENT EYE. NO PATIENT CONTACTS.
Patient problems: Insufficient Information
MAUDE report 23723505 ↗MalfunctionNov 18, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse
EXPERIENCED A FAILURE WITH ONE OF THE M. RING 7.0MM INJECTORS FROM OUR RECENT BOX, WHERE THE INJECTOR DID NOT DEPLOY AND INSTEAD CURLED WITHIN THE CAVITY. THIS DISRUPTED THE PROCEDURE, AND WE BELIEVE THE PRODUCT MAY HAVE BEEN FAULTY. MR USED AS PER DFU - SURGEON IS EXPERIENCED. OPENED A NEW MALYUGIN RING (6.25) AS THE COMPLAINT SAMPLE IS THE LAST IN THE BOX. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 23589588 ↗
Other Clip, Iris Retractor devices
- Malyugin Ring System 2.0, 6.25mm MAL-1001-1Microsurgical Technology, Inc. · Clip, Iris Retractor81 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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