Alcon Research product recalled over mold contamination

Recall date

April 28, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Alcon Research, Ltd. recalls CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks

Recall number

Z-1940-2016

FDA classification

Class II

Brand / firm

Alcon Research, Ltd.

Sold / distributed

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, Phil…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks