Malyugin Ring System 2.0, 6.25mm MAL-1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10844685006127), received between Jul 24, 2023 and Jul 27, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2023Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  THE MALYUGIN RING CAME OUT OF THE INJECTOR UPSIDE DOWN IT COULD NOT BE MANIPULATED AND CAUSED A TEAR IN THE IRIS.

  Patient problems: Eye Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402971 ↗
• InjuryJul 24, 2023Material Fragmentation; Material Fragmentation

  WHILE REMOVING THE MALYUGIN RING FROM THE EYE, THE SURGEON NOTICED SMALL GOLD FLECKS IN THE EYE. SOME WERE REMOVED DURING THE IRRIGATION PROCESS BUT IT WAS NOTICED IN THE FOLLOW UP THAT THERE WERE STILL 3 GOLD FLECKS NOTICED: ONE ON THE IRIS AND 2 IN THE INCISION. SURGEON STATED THAT NONE OF THE OTHER DEVICES THAT WERE USED DURING SURGERY HAD ANY GOLD ON THEM. IN NORMAL POST-OP SCHEDULE AND DROPS, THE OUTCOME WAS REPORTED GOOD WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376103 ↗