LEGION, INTREPID, KELMANRecalls & reported problems across all models
Alcon Laboratories, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one LEGION, INTREPID, KELMAN model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of LEGION, INTREPID, KELMAN by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Aug 19, 2025 and Aug 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
LEGION, INTREPID, KELMAN recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 28, 2023Open, Classified
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.
Z-2409-2023 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported LEGION, INTREPID, KELMAN problems
Device problems
- Break1
Patient problems
- Insufficient Information1
LEGION, INTREPID, KELMAN models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LEGION, INTREPID, KELMAN 8065753166Unit, Phacofragmentation1 recall1 report
- LEGION, INTREPID, KELMAN 8065753165Unit, Phacofragmentation1 recall0 reports
Recent LEGION, INTREPID, KELMAN adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT THE PHACOEMULSIFICATION TIP BROKEN DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON SAME DAY. IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 22837437 ↗
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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