CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
Medical device recall Z-1940-2016. Published in FDA’s Enforcement Report on Jun 15, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 15, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 156,712 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
156,712 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,993 characters
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…
FDA’s list runs to 2,334 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 28, 2016.
- FDA classified it on Jun 9, 2016.
- FDA’s Enforcement Report published it on Jun 15, 2016.
- FDA terminated it on Mar 31, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Alcon Research, Ltd., of Fort Worth, TX.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,334 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.