BIOFINITY XR TORIC 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 - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: N/A Lot Numbers: RD0122830 RD0122954 RD0122963 RD0123016 RD0123055 RD0123135 RD0123147 RD0123159 RD0123160 RD0123172 RD0123187 RD0123193 RD0123197 RD0123206 RD0123212 RD0123250 RD0123254 RD0123261 RD0123265 RD0123268 RD0123284 RD0123294 RD0123307 RD0123321 RD0123323 RD0123327 RD0123346 RD0123347 RD0123379 RD0123382 RD0123404 RD0123405 RD0123408 RD0123419 RD0123428 RD0123433 RD0123442 RD0123488 RD0123492 RD0123499 RD0123507 RD0123535 RD0123551 RD0123587 RD0123595 RD0123610 RD0123615 RD0123619 RD0123628 RD0123646 RD0123657 RD0123667 RD0123675 RD0123698 RD0123701 RD0123705 RD0123728 RD0123730 RD0123734 RD0123751 RD0123818 RD0123827 RD0123857 RD0123863 RD0123897 RD0123915 RD0123945 RD0123960 RD0123970 RD0124002 RD0124026 RD0124043 RD0124060 RD0124099 RD0124137 RD0124209 RD0124210 RD0124215 RD0124225 RD0124241 RE0071577 RE0071578 RE0071598 RE0071606 RE0071607 RE0071613 RE0071615 RE0071616 RE0071617 RE0071619 RE0071620 RE0071622 RE0071623 RE0071624 RE0071627 RE0071629 RE0071636 RE0071641 RE0071656 RE0071758 RE0071807 RE0071821 RE0071827 RE0071830 RE0071836 RE0071840 RE0071853 RE0071858 RE0071863 RE0071864 RE0071869 RE0071873 RE0071879 RE0071881 RE0071883 RE0071889 RE0071892 RE0071897 RE0071905 RE0071906 RE0071923 RE0071926 RE0071942 RE0071943 RE0071947 RE0071953 RE0071995 RE0071996 RE0072056 RE0072271 RE0072283 RE0072297 RE0072481 RE0072502
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 XR TORIC 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: RD0122830 RD0122954 RD0122963 RD0123016 RD0123055 RD0123135 RD0123147 RD0123159 RD0123160 RD0123172 RD0123187 RD0123193 RD0123197 RD0123206 RD0123212 RD0123250 RD0123254 RD0123261 RD0123265 RD0123268 RD0123284 RD0123294 RD0123307 RD0123321 RD0123323 RD0123327 RD0123346 RD0123347 RD0123379 RD0123382 RD0123404 RD0123405 RD0123408 RD0123419 RD0123428 RD0123433 RD0123442 RD0123488 RD0123492 RD0123499 RD0123507 RD0123535 RD0123551 RD0123587 RD0123595 RD0123610 RD0123615 RD0123619 RD0123628 RD0123646 RD0123657 RD0123667 RD0123675 RD0123698 RD0123701 RD0123705 RD0123728 RD0123730 RD0123734 RD0123751 RD0123818 RD0123827 RD0123857 RD0123863 RD0123897 RD0123915 RD0123945 RD0123960 RD0123970 RD0124002 RD0124026 RD0124043 RD0124060 RD0124099 RD0124137 RD0124209 RD0124210 RD0124215 RD0124225 RD0124241 RE0071577 RE0071578 RE0071598 RE0071606 RE0071607 RE0071613 RE0071615 RE0071616 RE0071617 RE0071619 RE0071620 RE0071622 RE0071623 RE0071624 RE0071627 RE0071629 RE0071636 RE0071641 RE0071656 RE0071758 RE0071807 RE0071821 RE0071827 RE0071830 RE0071836 RE0071840 RE0071853 RE0071858 RE0071863 RE0071864 RE0071869 RE0071873 RE0071879 RE0071881 RE0071883 RE0071889 RE0071892 RE0071897 RE0071905 RE0071906 RE0071923 RE0071926 RE0071942 RE0071943 RE0071947 RE0071953 RE0071995 RE0071996 RE0072056 RE0072271 RE0072283 RE0072297 RE0072481 RE0072502
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-3310-2024
Related Recalls
One lot manufactured with an invalid sterilization cycle.
One lot manufactured with an invalid sterilization cycle.
One lot manufactured with an invalid sterilization cycle.