CLASS II ONGOING Device recall · Reported 9 Oct 2024 · FDA Enforcement Report

Biofinity XR Toric Lenses - Soft Contact lenses Indicated recalled

CooperVision is recalling Biofinity XR Toric Lenses - Soft Contact lenses Indicated for the correction of ametropia, distributed nationwide in the US. The recall was initiated on 29 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-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

Quantity recalled607 lenses

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3310-2024
FDA event ID: 95299
Recalling firm: CooperVision, West Henrietta, NY
Classification: Class II
Status: Ongoing
Recall initiated: 29 Aug 2024
FDA classified: 30 Sep 2024
Reported: 9 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Contact Lenses & Eye Devices

Timeline

29 Aug 2024	Recall initiated by company
30 Sep 2024	Classified by FDA	+32 days
9 Oct 2024	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Why was it recalled?

Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 95299

This product is part of a recall event; the main page for the event is Biofinity Toric Multifocal Lenses recalled by CooperVision.

Reported	Class	Recall	Company	Reason	Where
9 Oct 2024	CLASS II	Biofinity Toric Multifocal Lenses recalled by CooperVision	CooperVision	Other	Nationwide

More recalls from CooperVision

All 34

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Pearle Vision 1 day (somofilcon A) Contact Lens recalled by CooperVision	CooperVision	Other	Nationwide
1 Oct 2025Device	CLASS II	Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision	CooperVision	Sterility	Nationwide
1 Oct 2025Device	CLASS II	Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled	CooperVision	Sterility	Nationwide
1 Oct 2025Device	CLASS II	MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision	CooperVision	Sterility	Nationwide
30 Jul 2025Device	CLASS II	Biofinity Toric Multifocal Contact Lens recalled by CooperVision	CooperVision	Packaging Defects	Nationwide

Other Contact Lenses & Eye Devices recalls

All 153

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Pearle Vision 1 day (somofilcon A) Contact Lens recalled by CooperVision	CooperVision	Other	Nationwide
1 Apr 2026Device	CLASS II	Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled	AMO Puerto Rico Manufacturing	Device Malfunction	Nationwide
5 Nov 2025Device	CLASS II	Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled	Alcon Research	Sterility	19 states
1 Oct 2025Device	CLASS II	Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision	CooperVision	Sterility	Nationwide
1 Oct 2025Device	CLASS II	Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled	CooperVision	Sterility	Nationwide