ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random…
Medical device recall Z-0134-2015. Published in FDA’s Enforcement Report on Nov 5, 2014.
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 Nov 5, 2014. Copied from openFDA on Oct 20, 2026.
- Class III FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 13639 lenses/246 product lots 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 III, the least serious of FDA’s three classes.
“Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.”
openFDA, in plain words, its enforcement report fields.
“Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
FDA’s rule, 21 CFR 7.3(m)(3), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling.
13639 lenses/246 product lots, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
10029500013022 10029550001022 10036550020022 10055500013022 10099500007022 10106500024022 10125500021022 10169500001022 10195550000022 10423500014022 10423550004022 10424500021022 10426500012022 10427500014022 10427500015022 10427500016022…
Every code shown here, 1,995 characters
10029500013022 10029550001022 10036550020022 10055500013022 10099500007022 10106500024022 10125500021022 10169500001022 10195550000022 10423500014022 10423550004022 10424500021022 10426500012022 10427500014022 10427500015022 10427500016022 10427500017022 10427500018022 10428500020022 10428500021022 10428500022022 10428500023022 10428500024022 10428500025022 10429500006022 10429550000022 10430500016022 10430500017022 10430500018022 10430500019022 10430500020022 10019550013017 10089500019017 10089500020017 10159500008017 10229550003017 10001500011008 10001500012008 10003550007008 10003550008008 10007500018008 10007500019008 10007550010008 10008500014008 10008500015008 10010550020008 10011500013008 10011550013008 10016550012008 10024500018008 10024550004008 10037500023008 10037550008008 10043500019008 10043500020008 10044550009008 10044550010008 10045500015008 10045500016008 10046500024008 10046550006008 10052500021008 10052550006008 10052550007008 10053550012008 10053550013008 10073500023008 10073500024008 10073500025008 10077500031008 10077500032008 10077500033008 10078500032008 10078500033008 10080550002008 10086500022008 10086500023008 10094500017008 10094500018008 10107500027008 10107500028008 10107550003008 10113500023008 10113500024008 10114500029008 10115500026008 10115500027008 10115550002008 10116500029008 10116500030008 10116550002008 10122500020008 10123500030008 10148550001008 10156500016008 10156550004008 10183550000008 10183550001008 10184500006008 10185500007008 10192500005008 10193500014008 10211550004008 10213500017008 10217500016008 10218500014008 10226500023008 10234500010008 10234500011008 10247500020008 10247500021008 10253500009008 10254500014008 10255500020008 10255500021008 10256500010008 10262500014008 10263550000008 10009550018007 10014500016007 10014500017007 10020500020007 10020500021007 10054550013007 10084500019007 10084500020007 10090500023007 10124500028007 10154550000007 10160500009007 10194500017007 10194550003007 10224500011007…
FDA’s list runs to 3,689 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: US (nationwide) and internationally to: Canada, Latin America, EU, Asia Pacific, and Africa/Central Eurasia countries.
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 Sep 17, 2014.
- FDA classified it on Oct 24, 2014.
- FDA’s Enforcement Report published it on Nov 5, 2014.
- FDA terminated it on Jun 10, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cooper Vision Caribbean Corp., of Juana Diaz, PR.
- 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 3,689 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
-
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.