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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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 RB0452262 RB0452263 RB0452275 RB0452278 RB0452280 RB0452281 RB0452284 RB0452298 RB0452300 RB0452303 RB0452307 RB0452308 RB0452309 RB0452313 RB0452314 RB0452316 RB0452320 RB0452321 RB0452322 RB0452325 RB0452326 RB0452348 RB0452349 RB0452425 RB0452430 RB0452462 RB0452485 RB0452502 RB0452669 RB0452781 RB0452786 RB0452793 RB0452794 RB0452805 RB0452807 RB0452808 RB0452821 RB0452830 RB0452831 RB0452954 RB0452984 RB0453226 RB0453778 RC1241675 RC1241913 RC1241915 RC1241921 RC1241955 RC1242264 RC1242265 RC1242268 RC1242309 RC1242323 RC1242369 RC1242376 RC1242401 RC1242409 RC1242420 RC1242437 RC1242449 RC1242457 RC1242469 RC1242611 RC1242622 RC1242623 RC1242632 RC1242657 RC1242688 RC1242755 RC1242756 RC1242794 RC1242796 RC1242802 RC1242808 RC1242816 RC1242817 RC1242863 RC1242866 RC1242963 RC1242973 RC1243012 RC1243017 RC1243035 RC1243043 RC1243058 RC1243061 RC1243078 RC1243115 RC1243141 RC1243156 RC1243173 RC1243184 RC1243189 RC1243198 RC1243223 RC1243257 RC1243258 RC1243297 RC1243304 RC1243306 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  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
CooperVision, Inc.
Reason for Recall:
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

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 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Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3311-2024

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