Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision Recalled by Alcon Research, Ltd. Due to Alcon is conducting this Voluntary Medical Device Removal...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alcon Research, Ltd. directly.
Affected Products
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
Quantity: 156,712 units
Why Was This Recalled?
Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.
Where Was This Sold?
US, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colunbia, Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay
About Alcon Research, Ltd.
Alcon Research, Ltd. has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report