LEGION 8065753037Recalls & reported problems
Alcon Laboratories, Inc. · LEGION System, MultiPak FMS, BASIC · Class 2
All models of LEGION (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380657530373), received between Jul 25, 2025 and Jul 25, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (2 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.
Reports received per month
Most reported problems
Device problems
- Infusion or Flow Problem2
Patient problems
- Endophthalmitis2
- Inflammation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2025Infusion or Flow Problem; Infusion or Flow Problem
A HEALTHCARE PROFESSIONAL REPORTED VENTILATION FILTERS WAS NOT GOOD AND DID NOT DRAW AIR AS SOON AS A VACUUM FORMS IN THE BOTTLE DURING SURGERY. A CANNULA WAS INSERTED INTO THE TOP OF THE BOTTLE TO MAKE IT RUN. IT WAS MEANT THAT THE SOLUTION WAS NO LONGER STERILE. THERE WAS INFLAMED EYES AND ENDOPHTHALMITIS REPORTED. THE SURGERY DETAILS WERE NOT REPORTED.
Patient problems: Endophthalmitis; Inflammation
MAUDE report 22608115 ↗InjuryJul 25, 2025Infusion or Flow Problem; Infusion or Flow Problem
A HEALTHCARE PROFESSIONAL REPORTED VENTILATION FILTERS WAS NOT GOOD AND DID NOT DRAW AIR AS SOON AS A VACUUM FORMS IN THE BOTTLE DURING SURGERY. A CANNULA WAS INSERTED INTO THE TOP OF THE BOTTLE TO MAKE IT RUN. IT WAS MEANT THAT THE SOLUTION WAS NO LONGER STERILE. THERE WAS INFLAMED EYES AND ENDOPHTHALMITIS REPORTED. THE SURGERY DETAILS WERE NOT REPORTED.
Patient problems: Endophthalmitis; Inflammation
MAUDE report 22607404 ↗
Other Unit, Phacofragmentation devices
- Centurion 8065751763Alcon Laboratories, Inc. · Unit, phacofragmentation728 reports
- Centurion 8065753057Alcon Laboratories, Inc. · Unit, phacofragmentation639 reports
- CENTURION® 8065752914Alcon Laboratories, Inc. · Unit, phacofragmentation571 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls398 reports
- Alcon 8065752201Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall386 reports
- Alcon 8065752200Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall366 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls302 reports
- Constellation, ULTRAVIT, Engauge, 25+ 8065752415Alcon Laboratories, Inc. · Unit, phacofragmentation369 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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