LEGION 8065753027Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380657530274), received between Oct 24, 2024 and Mar 17, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Suction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT VACUUM STOPPED BUILDING DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED BY USING SECOND CASSETTE. THERE WAS NO PATIENT IMPACT.

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

  MAUDE report 24614923 ↗
• MalfunctionFeb 18, 2026Suction Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT MACHINE WAS NOT CREATING A VACUUM AND AN ERROR MESSAGE APPEARED ON THE SCREEN STATING THAT THE CASSETTE REQUIRED REPLACEMENT DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED ON SAME DAY BY REPLACING THE CASSETTE WITH NEW ONE. THERE WAS NO INFORMATION REPORTED ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. RESPONSE AWAITED.

  Patient problems: Insufficient Information

  MAUDE report 24374828 ↗
• MalfunctionJan 21, 2026Material Separation

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE IRRIGATION TUBING DISLODGED DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO REPORTED INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 24128780 ↗
• MalfunctionAug 14, 2025Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE ASPIRATION WAS NOT AVAILABLE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806711 ↗
• MalfunctionFeb 25, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut

  A NURSE REPORTED WHILE IT WAS IN THE QUADRANT MODULE, IT DID NOT CUT THE CATARACT OR ASPIRATE DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE PATIENT FELT PAIN. THE WHOLE KIT WAS CHANGED AND THE WHOLE PROCESS STARTED AGAIN, WITH NO PROBLEMS IN THE SECOND KIT THAT WAS OPENED AND INSTALLED. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS A PATIENT CONTACT. THE PATIENT CONDITION WAS RESOLVED.

  Patient problems: Eye Pain

  MAUDE report 21455767 ↗
• MalfunctionOct 24, 2024Suction Problem; Suction Problem

  THE PHYSICIAN REPORTED THAT VACUUM BUILDING SUDDENLY STOPPED ADVISORY OR ERROR MESSAGE WAS COMING DURING THE CATARACT SURGERY. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20520277 ↗