Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE
Medical device recall Z-0542-2014. Published in FDA’s Enforcement Report on Dec 25, 2013.
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 25, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 153 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?
Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses
153 cartons, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot 361950571720, potential incorrect expiry date 1/2018; Lot 361950575934, potential incorrect expiry date 9/2017; Lot 361950589008, potential incorrect expiry date 2/2018; Lot 361950590915, potential incorrect expiry date 8/2018; Lot…
Every code shown here, 1,999 characters
Lot 361950571720, potential incorrect expiry date 1/2018; Lot 361950575934, potential incorrect expiry date 9/2017; Lot 361950589008, potential incorrect expiry date 2/2018; Lot 361950590915, potential incorrect expiry date 8/2018; Lot 361950597210, potential incorrect expiry date 7/2017; Lot 361950599011, potential incorrect expiry date 8/2018; Lot 361950599816, potential incorrect expiry date 9/2017; Lot 361950606714, potential incorrect expiry date 12/2017; Lot 361950608721, potential incorrect expiry date 6/2018; Lot 361950613813, potential incorrect expiry date 1/2018; Lot 361950632507, potential incorrect expiry date 3/2018; Lot 361950638202, potential incorrect expiry date 2/2017; Lot 361950644719, potential incorrect expiry date 10/2018; Lot 361950646326, potential incorrect expiry date 10/2018; Lot 361950647128, potential incorrect expiry date 10/2018; Lot 361950676608, potential incorrect expiry date 12/2018; Lot 361950682615, potential incorrect expiry date 10/2017; Lot 361950684220, potential incorrect expiry date 10/2019; Lot 361950691505, potential incorrect expiry date 1/2017; Lot 361950692806, potential incorrect expiry date 7/2018; Lot 361950706108, potential incorrect expiry date 12/2018; Lot 361950706308, potential incorrect expiry date 1/2015; Lot 361950711903, potential incorrect expiry date 7/2018; Lot 361950712707, potential incorrect expiry date 2/2017; Lot 361950742714, potential incorrect expiry date 1/2017; Lot 361950744516, potential incorrect expiry date 10/2017; Lot 361950767118, potential incorrect expiry date 4/2018; Lot 361950778620, potential incorrect expiry date 1/2018; Lot 361950789608, potential incorrect expiry date 4/2018; Lot 361950800811, potential incorrect expiry date 3/2017; Lot 361950826215, potential incorrect expiry date 3/2018; Lot 361950829333, potential incorrect expiry date 9/2017; Lot 361950839008, potential incorrect expiry date 4/2017; Lot 361950845916, potential incorrect expiry date 3/2018; Lot 361950859017,…
FDA’s list runs to 2,924 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.
Worldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Nov 20, 2013.
- FDA classified it on Dec 19, 2013.
- FDA’s Enforcement Report published it on Dec 25, 2013.
- FDA terminated it on Jul 22, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CooperVision Inc., of W Henrietta, NY.
- 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 2,924 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.