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U.S. Department of Health and Human Services

Class 2 Device Recall CENTURION Vision System

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  Class 2 Device Recall CENTURION Vision System see related information
Date Initiated by Firm April 28, 2016
Date Posted June 09, 2016
Recall Status1 Terminated 3 on March 31, 2017
Recall Number Z-1940-2016
Recall Event ID 73998
510(K)Number K121555  
Product Classification Unit, phacofragmentation - Product Code HQC
Product CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
Code Information Lot Numbers:  1785989H 1785990H 1786004H 1786005H 1786006H 1786007H 1791520H 1791521H 1791522H 1791523H 1791524H 1791525H 1791526H 1791527H 1791528H 1791529H 1791845H 1791846H 1793690H 1793706H 1793707H 1793709H 1793710H 1793711H 1793712H 1793713H 1793714H 1793715H 1793716H 1794101H 1794102H 1794103H 1794104H 1794105H 1794106H 1794107H 1794108H 1794153H 1794154H 1794155H 1794156H 1794157H 1794158H 1794159H 1794160H 1794161H 1794162H 1794163H 1794164H 1794165H 1794166H 1794167H 1794168H 1794544H 1794545H 1794546H 1794547H 1794548H 1794549H 1794550H 1794551H 1794552H 1794553H 1794554H 1794555H 1794556H 1794557H 1794558H 1794559H 1794560H 1794561H 1794562H 1794563H 1794564H 1794565H 1822927H 1822928H 1822929H 1794169H 1794175H 1794176H 1794566H 1794567H 1794568H 1794569H 1794570H 1794571H 1794572H 1796505H 1796506H 1799220H 1799221H 1799222H 1799223H 1799224H 1799225H 1799226H 1799227H 1799228H 1799229H 1799230H 1799231H 1799232H 1799233H 1799248H 1799249H 1799250H 1799251H 1799252H 1799253H 1799254H 1799255H 1799256H 1799257H 1799259H 1799260H 1799297H 1799333H 1799334H 1799335H 1799336H 1799337H 1799338H 1799339H 1799340H 1799341H 1799342H 1799344H 1799345H 1799346H 1799347H 1799348H 1799349H 1799350H 1799351H 1799352H 1799353H 1799354H 1799355H 1799505H 1799506H 1799548H 1799583H 1799584H 1799585H 1799586H 1799587H 1799588H 1799589H 1799590H 1799591H 1799592H 1799593H 1799594H 1799595H 1799596H 1799597H 1799598H 1799599H 1799600H 1799601H 1799602H 1799603H 1799604H 1799605H 1799606H 1799607H 1799608H 1799609H 1799610H 1799611H 1799612H 1799613H 1799614H 1799615H 1799616H 1799838H 1801714H 1801716H 1801717H 1801720H 1801721H 1801723H 1801725H 1801726H 1802250H 1802251H 1802252H 1802253H 1802254H 1802296H 1802297H 1802298H 1802299H 1802300H 1802301H 1802307H 1802309H 1802310H 1802311H 1802314H 1802316H 1802317H 1802318H 1802319H 1802320H 1802422H 1804658H 1804659H 1804660H 1804661H 1804665H 1804666H 1804668H 1804670H 1804671H 1804687H 1804688H 1804689H 1804690H 1804691H 1804692H 1804693H 1804696H 1804697H 1804698H 1804699H 1804846H 1804847H 1804848H 1804849H 1804906H 1805300H 1807851H 1810778H 1810784H 1810785H 1810786H 1810810H 1810811H 1810816H 1810819H 1810821H 1810822H 1810823H 1810866H 1810868H 1813648H 1820467H 1820468H 1850236H 1852102H 1852312H 1852313H 1855616H 1856223H 1857679H 1858039H 
Recalling Firm/
Alcon Research, Ltd.
6201 South Fwy
Fort Worth TX 76134-2099
For Additional Information Contact Customer Service
Manufacturer 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.
FDA Determined
Cause 2
Process control
Action The affected consignees were sent a recall notification letter on 4/28/16.
Quantity in Commerce 156,712 units
Distribution 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HQC and Original Applicant = ALCON LABORATORIES, INC.