CLASS II ONGOING Device recall · Reported 30 Jul 2025 · FDA Enforcement Report

Biofinity Toric Multifocal Contact Lens recalled by CooperVision

CooperVision is recalling Biofinity Toric Multifocal Contact Lens, distributed nationwide in the US. The recall was initiated on 16 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCarton Lot Numbers: RB0682365, RB0684301, RB0684305, RB0684311, RB0684313, RB0684317, RB0684321, RB0684325, RB0684335, RB0684506, RB0684575, RB0684582, RB0684653, RB0684657, RB0684659, RB0684663, RB0684664, RB0684667, RB0684668, RB0684669, RB0684670, RB0684673, RB0684674, RB0684676, RB0684682, RB0686359, RB0687092, RB0687368, RB0687370, RB0687547, RB0687582, RB0687586, RB0687665, RB0687693, RB0687797, RB0687800, RB0687801, RB0687802, RB0687803, RB0687807, RB0687812, RB0687822, RB0687893, RB0687897, RB0687904, RB0687908, RB0687910, RB0687922, RB0688105, RB0688107, RB0688109, RB0688113, RB0688117, RB0688121, RB0688128, RB0688130, RB0688145, RB0688147, RB0688151, RB0688163, RB0688170, RB0688174, RB0688269, RB0688298, RB0688300, RB0688305, RB0688307, RB0688320, RB0688322, RB0688343, RB0688492, RC1756323, RC1759660, RC1759663, RC1759931, RC1759947, RC1759965, RC1759967

Quantity recalled827 units

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-2166-2025
FDA event ID: 97173
Recalling firm: CooperVision, Scottsville, NY
Classification: Class II
Status: Ongoing
Recall initiated: 16 Jun 2025
FDA classified: 23 Jul 2025
Reported: 30 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Contact Lenses & Eye Devices

Timeline

16 Jun 2025	Recall initiated by company
23 Jul 2025	Classified by FDA	+37 days
30 Jul 2025	Published in enforcement report	+7 days

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

Reason for recall

Lens blisters may have an incomplete or leaking seal which may render them unsterile.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Biofinity Toric Multifocal Contact Lens

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.

Nationwide

Questions about this recall

Why was it recalled?

Lens blisters may have an incomplete or leaking seal which may render them unsterile.

Which lots are affected?

Carton Lot Numbers: RB0682365, RB0684301, RB0684305, RB0684311, RB0684313, RB0684317, RB0684321, RB0684325, RB0684335, RB0684506, RB0684575, RB0684582, RB0684653, RB0684657, RB0684659, RB0684663, RB0684664, RB0684667, RB0684668, RB0684669, RB0684670, RB0684673, RB0684674, RB0684676, RB0684682, RB0686359, RB0687092, RB0687368, RB0687370, RB0687547, RB0687582, RB0687586, RB0687665, RB0687693, RB0687797, RB0687800, RB0687801, RB0687802, RB0687803, RB0687807, RB0687812, RB0687822, RB0687893, RB0687897, RB0687904, RB0687908, RB0687910, RB0687922, RB0688105, RB0688107, RB0688109, RB0688113, RB0688117, RB0688121, RB0688128, RB0688130, RB0688145, RB0688147, RB0688151, RB0688163, RB0688170, RB0688174, RB0688269, RB0688298, RB0688300, RB0688305, RB0688307, RB0688320, RB0688322, RB0688343, RB0688492, RC1756323, RC1759660, RC1759663, RC1759931, RC1759947, RC1759965, RC1759967

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.

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 97173

This product is part of a recall event; the main page for the event is Biofinity XR Toric Contact Lens recalled by CooperVision.

Reported	Class	Recall	Company	Reason	Where
30 Jul 2025	CLASS II	Biofinity XR Toric Contact Lens recalled by CooperVision	CooperVision	Packaging Defects	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 XR Toric 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