Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or…
Medical device recall Z-3311-2024. Published in FDA’s Enforcement Report on Oct 9, 2024.
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 Oct 9, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2443 lenses 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?
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
2443 lenses, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: N/A Lot Numbers: RB0444532 RB0450357 RB0450370 RB0450372 RB0450378 RB0450379 RB0450407 RB0450419 RB0450422 RB0450429 RB0450438 RB0450446 RB0450455 RB0450457 RB0450465 RB0450466 RB0450477 RB0450478 RB0450496 RB0450501 RB0450504…
Every code shown here, 1,995 characters
UDI-DI: N/A Lot Numbers: RB0444532 RB0450357 RB0450370 RB0450372 RB0450378 RB0450379 RB0450407 RB0450419 RB0450422 RB0450429 RB0450438 RB0450446 RB0450455 RB0450457 RB0450465 RB0450466 RB0450477 RB0450478 RB0450496 RB0450501 RB0450504 RB0450542 RB0450547 RB0450548 RB0450560 RB0450561 RB0450575 RB0450594 RB0450613 RB0450625 RB0450636 RB0450646 RB0450649 RB0450653 RB0450657 RB0450659 RB0450686 RB0450687 RB0450688 RB0450691 RB0450693 RB0450694 RB0450695 RB0450697 RB0450699 RB0450701 RB0450702 RB0450707 RB0450708 RB0450709 RB0450710 RB0450714 RB0450719 RB0450727 RB0450730 RB0450739 RB0450746 RB0450748 RB0450753 RB0450767 RB0450770 RB0450776 RB0450827 RB0450864 RB0450887 RB0450957 RB0451097 RB0451099 RB0451101 RB0451104 RB0451106 RB0451107 RB0451122 RB0451127 RB0451130 RB0451134 RB0451135 RB0451136 RB0451137 RB0451139 RB0451403 RB0451430 RB0451433 RB0451442 RB0451443 RB0451451 RB0451456 RB0451462 RB0451468 RB0451485 RB0451488 RB0451546 RB0451553 RB0451558 RB0451587 RB0451593 RB0451604 RB0451611 RB0451622 RB0451627 RB0451644 RB0451648 RB0451657 RB0451658 RB0451666 RB0451671 RB0451685 RB0451687 RB0451691 RB0451697 RB0451706 RB0451707 RB0451713 RB0451720 RB0451724 RB0451725 RB0451729 RB0451730 RB0451731 RB0451736 RB0451737 RB0451738 RB0451746 RB0451748 RB0451750 RB0451751 RB0451761 RB0451788 RB0451789 RB0451790 RB0451791 RB0451792 RB0451794 RB0451801 RB0451810 RB0451812 RB0451813 RB0451817 RB0451823 RB0451824 RB0451828 RB0451841 RB0451842 RB0451843 RB0451844 RB0451845 RB0451847 RB0451883 RB0451884 RB0451945 RB0451957 RB0451958 RB0451961 RB0451964 RB0451965 RB0451966 RB0451973 RB0451976 RB0451978 RB0451982 RB0451983 RB0451987 RB0451993 RB0452006 RB0452009 RB0452010 RB0452012 RB0452016 RB0452018 RB0452020 RB0452027 RB0452028 RB0452035 RB0452036 RB0452042 RB0452045 RB0452104 RB0452107 RB0452133 RB0452159 RB0452164 RB0452171 RB0452215 RB0452219 RB0452227 RB0452228 RB0452229 RB0452230 RB0452231 RB0452239 RB0452242 RB0452243 RB0452246 RB0452255 RB0452258 RB0452260 RB0452261…
FDA’s list runs to 5,864 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 the country of Canada.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 29, 2024.
- FDA classified it on Sep 30, 2024.
- FDA’s Enforcement Report published it on Oct 9, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CooperVision, Inc., of West 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 5,864 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.