Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx,…
Medical device recall Z-0609-2020. Published in FDA’s Enforcement Report on Dec 11, 2019.
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 Dec 11, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Completed its status, in FDA’s file
- Not named no state, in where it went
- 1,600/6-contact lens cartons 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 may be counterfeit and could have microbial issues.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
1,600/6-contact lens cartons, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot numbers 31248224, exp. 2021/06; 31251806, exp. 2021/07; 31252524, exp. 2021/07; 31202568, exp. 2020/09; 31247324, exp. 2021/06; 31255298, exp. 2021/08; 31231184, exp. 2021/03; 31257909, exp. 2021/08; 31247744, exp. 2021/06; 31240720,…
Every code shown here, 515 characters
Lot numbers 31248224, exp. 2021/06; 31251806, exp. 2021/07; 31252524, exp. 2021/07; 31202568, exp. 2020/09; 31247324, exp. 2021/06; 31255298, exp. 2021/08; 31231184, exp. 2021/03; 31257909, exp. 2021/08; 31247744, exp. 2021/06; 31240720, exp. 2021/04; 31252252, exp. 2021/07; 31251559, exp., 2021/07; 31243321, exp. 2021/05; 31259174, 2021/09; 31256939, exp. 2021/08; 31257917, exp. 2021/08; 31256939, exp. 2021/08; 31257917, exp. 2021/08; 31242179, exp. 2021/05; 31251806, exp. 2021/07; and 31252524, exp. 2021/07.
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.
Due to HIPAA, the firm only provided a spreadsheet that contained the first name, last initial, and zip code of each customer who received email notification of the recall. Out of the 23,444 unique names on this list (25,162 names were actually listed due to multiple consumer orders), the firm believes approximately 800 of them to have received potentially counterfeit product. The recalling firm was requested to provide a consumer spreadsheet showing the name, shipping address, and email address but declined because they thought it would be a violation of HIPAA regulations.
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Completed, in FDA’s file.
“The recall action reaches the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.”
openFDA, on “Completed”, 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 14, 2018.
- FDA classified it on Dec 5, 2019.
- FDA’s Enforcement Report published it on Dec 11, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Lens.com, of Las Vegas, NV.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
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.”
- 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.