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Terminated

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

FDA Recall Z-1940-2016 · Posted 2016-06-09

Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeHQC
Date Initiated2016-04-28
Date Terminated2017-03-31
Product Quantity156,712 units

Reason for Recall

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.

Firm Action

The affected consignees were sent a recall notification letter on 4/28/16.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121555CENTURION VISION SYSTEMAlcon Laboratories, Inc. · 2012-12-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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