LEGION 8065753050Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380657530502), received between Feb 7, 2024 and Jul 9, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25760160 ↗
• MalfunctionJul 8, 2026Failure to Cut

  A CUSTOMER REPORTED THAT BEFORE VITRECTOMY SURGERY, AN OPHTHALMIC HANDPIECE WAS NOT WORKING. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25750030 ↗
• MalfunctionFeb 27, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY PROCEDURE HANDPIECE WAS NOT WORKING, VIBRATION OR SOUND WAS NOT OBSERVED. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470668 ↗
• MalfunctionOct 23, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, THE OPHTHALMIC HANDPIECE WAS NOT CUTTING AND DISPLAYED AN ADVISORY CODE. THE SURGERY WAS COMPLETED MANUALLY USING FORCEPS, WITHOUT THE USE OF A VITRECTOMY CUTTER. THERE WAS NO PATIENT CONTACT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366784 ↗
• MalfunctionAug 25, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT BEFORE SURGERY, AN OPHTHALMIC ANTERIOR VITRECTOR SUDDENLY STOPPED WORKING. THE DETAILS OF THE PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 22882741 ↗
• MalfunctionJun 20, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT DURING DEMONSTRATION OF VITRECTOMY HANDPIECE IT WAS TO FOUND BE NOT WORKING. PROCEDURE WAS COMPLETED BY OTHER MACHINE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296399 ↗
• MalfunctionFeb 11, 2025Failure to Cut; Failure to Cut

  ADDITIONAL INFORMATION RECEIVED INDICATES THE ISSUE OCCURRED DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED BY ANOTHER SYSTEM. THERE WAS NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354745 ↗
• MalfunctionFeb 6, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT DURING SURGERY, AN OPHTHALMIC ANTERIOR VITRECTOMY HANDPIECE WAS NOT WORKING. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE. THIS IS THE SECOND OF TWO REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322800 ↗
• MalfunctionJul 24, 2024Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT DURING CATARACT REMOVAL SURGERY, AN OPHTHALMIC ANTERIOR VITRECTOMY HANDPIECE WAS NOT WORKING. THE PROCEDURE WAS COMPLETED. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19816761 ↗
• MalfunctionJun 19, 2024Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT DURING SURGERY, AN OPHTHALMIC VITRECTOMY HANDPIECE NOT CUTTING. THE PROCEDURE WAS NOT COMPLETED. THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565528 ↗
• MalfunctionApr 8, 2024Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT THE OPHTHALMIC HANDPIECE VITRECTOMY WAS NOT ACTIVATED, THE BLADE DOES NOT MOVE. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19060057 ↗
• MalfunctionFeb 7, 2024Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC HANDPIECE FAILED TO CUT AND A SYSTEM MESSAGE WAS DISPLAYED. PROCEDURE WAS COMPLETED USING ANOTHER HANDPIECE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658583 ↗