LEGION 8065753075Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00380657530755), received between May 14, 2024 and Sep 28, 2026 — classified as 3 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026No Device Output

  A physician reported that during cataract surgery, an ophthalmic system presented with tortional power missing. The surgery was completed on the same day after changing the phacoemulsification tip and retuning of the handpiece. There was no further patient impact was reported. Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50913782 ↗
• MalfunctionSep 14, 2026No Device Output

  A customer reported that during cataract surgery with intra ocular les implantation, an ophthalmic console failed to deliver the phacoemulsification power. There was some object/debris noted underneath the treadle. After the area was cleaned, the treadle position correctly reached phacoemulsification mode (position three) upon full depression, and the phacoemulsification power delivery issue was resolved. The surgery then started without any problems and was completed without any issues. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755662 ↗
• MalfunctionSep 14, 2026Output below Specifications; Suction Failure

  A customer reported that an ophthalmic console exhibit insufficient vacuuming and a difference in the ultrasound's behavior. The details of the procedure and patient impact have not been provided. Additional information has been requested and none received at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50752305 ↗
• MalfunctionAug 21, 2026Suction Problem; Suction Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374788 ↗
• MalfunctionAug 7, 2026Suction Problem

  Patient problems: Insufficient Information

  MAUDE report 50176689 ↗
• MalfunctionJul 31, 2026Suction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098670 ↗
• InjuryJul 30, 2026Failure to Back-Up

  A customer reported that an ophthalmic console used for the cataract surgery user experienced the settings issue. The patient experienced posterior capsular tear during the quad procedure. No vitrectomy was required. The surgeon was able to proceed with single piece intraocular implantation and no medical intervention required. The current outcome of the patient condition was unknown. Additional information has been requested but is not available at the time of this report.This complaint pertains to ophthalmic system involved in the reported events.

  Patient problems: Capsular Bag Tear

  MAUDE report 50078746 ↗
• MalfunctionJul 29, 2026Display or Visual Feedback Problem; Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50066233 ↗
• MalfunctionJul 14, 2026Suction Problem

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC SYSTEM EXHIBITED DIFFICULTIES IN PHACO MODE ASPIRATION. THE PATIENT EXPERIENCED CORNEAL EDEMA. THE SURGERY WAS COMPLETED ON THE SAME DAY. CURRENTLY THE PATIENT IS RESOLVED WITH THE EVENT CAUSED.

  Patient problems: Corneal Edema

  MAUDE report 25812242 ↗
• MalfunctionJul 13, 2026No Device Output

  Patient problems: Insufficient Information

  MAUDE report 25795551 ↗
• MalfunctionJul 8, 2026Computer Operating System Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25746638 ↗
• MalfunctionJun 12, 2026No Device Output

  A CUSTOMER REPORTED THAT, AN OPHTHALMIC OPERATING SYSTEM DID NOT PROVIDE PHACOEMULSIFICATION (PHACO) POWER. PROCEDURE DETAILS AND TIMING OF THE EVENT ARE UNKNOWN. DETAILS REGARDING PATIENT HARM HAS NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25483617 ↗
• MalfunctionMay 20, 2026No Device Output

  A CUSTOMER REPORTED THAT, AN OPHTHALMIC OPERATING SYSTEM DID NOT EXHIBIT TORSIONAL ULTRASOUND. PROCEDURE DETAILS AND TIMING OF THE EVENT ARE UNKNOWN. DETAILS ON SURGERY COMPLETION AND PATIENT HARM HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 25227379 ↗
• MalfunctionMar 26, 2026Suction Failure

  A CUSTOMER REPORTED THAT DURING SURGERY, THE OPHTHALMIC SYSTEM WAS NOT BUILDING VACUUM IN IRRIGATION AND ASPIRATION MODE, AS WELL AS IN PHACOEMULSIFICATION MODE. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER MACHINE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697402 ↗
• MalfunctionJan 19, 2026Suction Problem

  A CUSTOMER REPORTED THAT, DURING CHOP MODE OF THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, AN OPHTHALMIC OPERATING SYSTEM EXHIBITED LOW VACUUM. THE SURGERY WAS COMPLETED BY REPRIMING THE CASSETTE WITHOUT ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24107612 ↗
• MalfunctionSep 16, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED THAT IN AN OPHTHALMIC SYSTEM WHEN AIR WAS ENTERING THE BALANCED SALT SOLUTION (BSS) BAG, THE VACUUM WAS NOT BEING PROPERLY MAINTAINED, AND THE CATARACT WAS NOT BEING ASPIRATED CORRECTLY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23062079 ↗
• MalfunctionSep 12, 2025Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT AN OPTHALMIC OPERATING SYSTEM EXHIBITED AN ISSUE THAT VITRECTOMY HANDPIECE WAS NOT WORKING. THE DETAILS OF PROCEDURE AND PATIENT HARM HAD NOT BEEN REPORTED. ADDITIONAL INFORMATION HAD BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23036459 ↗
• MalfunctionAug 8, 2025Failure to Deliver Energy; Failure to Deliver Energy

  A CUSTOMER REPORTED THAT AN OPHTHALMIC CONSOLE EXHIBITED LOSS OF PHACOEMULSIFICATION POWER. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TO DATE.

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

  MAUDE report 22747126 ↗
• MalfunctionJul 21, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT, DURING CATARACT SURGERY, THE OPHTHALMIC SYSTEM EXHIBITED AN INTERMITTENT VACUUM ISSUE IN PHACOEMULSIFICATION MODE. THE SURGERY WAS COMPLETED THE SAME DAY BY CHANGING THE FLUIDICS MODULE OF THE SYSTEM, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553333 ↗
• MalfunctionJul 17, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY IN AN OPHTHALMIC SYSTEM VACUUM WAS POOR AND NOT HOLDING THE NUCLEUS IN ALL THE STEPS. SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE FLUIDICS MANAGEMENT SYSTEM AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529770 ↗
• MalfunctionJul 9, 2025Failure to Cut; Failure to Cut

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC SYSTEM CUTTER WAS NOT WORKING. THE SURGERY WAS COMPLETED WITH ALTERNATIVE SYSTEM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456453 ↗
• MalfunctionJul 3, 2025Failure to Deliver Energy; Failure to Cut; Failure to Deliver Energy; Failure to Cut

  A CUSTOMER REPORTED THAT IN AN OPHTHALMIC SYSTEM FLUIDICS, ULTRASONICS & VITRECTOMY WERE NOT AVAILABLE. PROCEDURE DETAILS AND PATIENT IMPACT HAS NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT PROCEDURE TYPE WAS CATARACT AND EVENT OCCURRED BEFORE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394125 ↗
• MalfunctionJun 23, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY OPHTHALMIC SYSTEM CRASHED, AND THE SCREEN LOCKED WHEN SWITCHING FROM CORE TO CORTEX SUCTION. THE PROCEDURES REQUESTED ON THE SCREEN WERE PERFORMED WITHOUT SUCCESS. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306769 ↗
• MalfunctionMay 19, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A CUSTOMER REPORTED THAT AN OPHTHALMIC SYSTEM EXHIBITED AN ISSUE WITH THE IRRIGATION FLUID THAT WAS DIRECTLY GOING TO DRAIN BAG. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22043172 ↗
• MalfunctionFeb 18, 2025Failure to Deliver Energy; Failure to Deliver Energy

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING SYSTEM EXHIBITED NO PHACOEMULSIFICATION POWER. ADDITIONAL INFORMATION RECEIVED THAT THE EVENT OCCURRED DURING CATARACT SURGERY. SURGERY WAS COMPLETED BY PERFORMING SMALL INCISION CATARACT SURGERY (SICS). THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399377 ↗