23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical…
Medical device recall Z-1693-2016. Published in FDA’s Enforcement Report on May 25, 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 May 25, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Puerto Rico the one state its words name
- 225,000 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?
The product has potential to leak beyond their design specification.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of 23G and 25G Pars-Plana-Vitrectomy (PPV) surgeries.
225,000 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers: 1711482H 1711485H 1714709H 1714711H 1714712H 1714713H 1714715H 1714716H 1714717H 1714736H 1714737H 1714738H 1714739H 1717871H 1717872H 1717874H 1717895H 1717896H 1717902H 1726095H 1726102H 1726103H 1726104H 1726105H 1726106H…
Every code shown here, 1,993 characters
Lot Numbers: 1711482H 1711485H 1714709H 1714711H 1714712H 1714713H 1714715H 1714716H 1714717H 1714736H 1714737H 1714738H 1714739H 1717871H 1717872H 1717874H 1717895H 1717896H 1717902H 1726095H 1726102H 1726103H 1726104H 1726105H 1726106H 1726107H 1726118H 1726119H 1726120H 1726121H 1726122H 1731592H 1731595H 1731929H 1731930H 1731931H 1731932H 1731933H 1734476H 1734478H 1734479H 1734480H 1734481H 1734546H 1734547H 1734548H 1734549H 1734550H 1734551H 1734552H 1734559H 1734560H 1734561H 1734562H 1734563H 1734564H 1734565H 1734566H 1734567H 1734568H 1734569H 1734570H 1734571H 1734572H 1734573H 1734574H 1735125H 1735126H 1735127H 1735128H 1735129H 1735130H 1735131H 1735132H 1746173H 1746197H 1746198H 1746199H 1746200H 1746201H 1747011H 1747012H 1747013H 1747014H 1747015H 1749215H 1749216H 1749217H 1749218H 1749219H 1749220H 1749221H 1751293H 1753301H 1753302H 1753303H 1753323H 1753324H 1753325H 1753326H 1753327H 1753328H 1753329H 1753339H 1753342H 1753346H 1753347H 1753348H 1753360H 1753361H 1753362H 1753363H 1756285H 1756286H 1759094H 1759095H 1759096H 1759097H 1759098H 1759099H 1759100H 1759101H 1759171H 1759172H 1759173H 1759174H 1759175H 1759176H 1759182H 1759183H 1759185H 1759186H 1759195H 1759196H 1759197H 1759198H 1764487H 1764488H 1764489H 1764710H 1764711H 1764712H 1764713H 1764714H 1764715H 1764716H 1764717H 1764718H 1764719H 1764720H 1764721H 1764722H 1764723H 1764735H 1764736H 1767599H 1773000H 1773001H 1773015H 1773016H 1773017H 1773018H 1775519H 1775520H 1775521H 1775522H 1775523H 1775524H 1775525H 1775526H 1780757H 1780758H 1780759H 1780760H 1780761H 1780762H 1780763H 1783252H 1783259H 1783260H 1783261H 1783272H 1783273H 1783274H 1783275H 1783276H 1783293H 1783294H 1783295H 1783296H 1783298H 1783299H 1783300H 1785543H 1791450H 1791452H 1791478H 1791481H 1791484H 1791485H 1791486H 1794207H 1794208H 1794209H 1794210H 1794221H 1794222H 1794223H 1794224H 1794225H 1794226H 1794229H 1702839H 1702840H 1702841H 1708745H 1708746H 1708747H 1708749H 1708750H…
FDA’s list runs to 4,476 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.
United States, Argentina, Armenia, Australia, Azerbaijan, Bangladesh, Brbados, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Curacao, Cypress, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Lsreal, Italy, Japan, Korea, Lithuania, Malta, Mexico, Monaco, Netherlands, New Zealand, Pakistam, Philippines, Poland, Prtougal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay
The states and territories these words name
- Puerto Rico
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 Aug 11, 2015.
- FDA classified it on May 18, 2016.
- FDA’s Enforcement Report published it on May 25, 2016.
- FDA terminated it on Apr 20, 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 4,476 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.