Class II — Potential Health Hazard

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...

Date: April 28, 2016
Company: Alcon Research, Ltd.
Status: Terminated
Source: FDA (Device)

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.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report