LEGIONRecalls & reported problems across all models
Alcon Laboratories, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 61
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 5 models of LEGION by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 61 adverse event reports in the FDA's MAUDE database, received between Feb 7, 2024 and Sep 28, 2026 — classified as 5 injuries, 56 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (21 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LEGION problems
Device problems
- Failure to Cut21
- Suction Problem15
- No Device Output5
- Suction Failure5
- Failure to Deliver Energy3
- Adverse Event Without Identified Device or Use Problem2
- Decrease in Suction2
- Energy Output Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions33
- Insufficient Information25
- Corneal Edema2
- Endophthalmitis2
- Inflammation2
- Capsular Bag Tear1
- Eye Pain1
- Rupture1
LEGION models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LEGION 8065753075Unit, Phacofragmentation40 reports
- LEGION 8065753050Unit, Phacofragmentation12 reports
- LEGION 8065753027Unit, Phacofragmentation6 reports
- LEGION 8065753037Unit, Phacofragmentation2 reports
- LEGION 8065753056Unit, Phacofragmentation1 report
Recent LEGION adverse event reports
The 15 most recent reports across all models, 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 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 ↗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 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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