Contact Lenses & Eye Devices recalls

153 medical device recalls in the contact lenses & eye devices category are on file with the FDA, from 2013 to 30 Sep 2026.

Total recalls153since 2013

Last 12 months3reported

Class I43% of total

Ongoing50latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 1 0Feb 0 2 2May 1 2 0Aug 1 3 1Nov 0 0 0Feb 0 1 0May 0 0 0Aug 1 0

Severity split

Class I 4 3%Class II 141 92%Class III 8 5%

Why contact lenses & eye devices is recalled

Companies

By year

202621%
2025138%
202453%
20231812%
202243%
20211610%
20201510%
201932%
2018128%
201764%

Ongoing contact lenses & eye devices recalls

50 active

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
1 Oct 2025Device	CLASS II	MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision	CooperVision	Sterility	Nationwide

All contact lenses & eye devices recalls, newest first

153 total

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
1 Oct 2025Device	CLASS II	MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision	CooperVision	Sterility	Nationwide
3 Sep 2025Device	CLASS III	Akreos, SKU: AO60P0300. Akreos intraocular lenses recalled	Bausch & Lomb Surgical	Other	AZ, CA
30 Jul 2025Device	CLASS II	Biofinity Toric Multifocal Contact Lens recalled by CooperVision	CooperVision	Packaging Defects	Nationwide
30 Jul 2025Device	CLASS II	Biofinity XR Toric Contact Lens recalled by CooperVision	CooperVision	Packaging Defects	Nationwide
18 Jun 2025Device	CLASS II	Contamac, Nutrifill Physiologic formula recalled by Contamac Solutions	Contamac Solutions	Sterility	Nationwide
14 May 2025Device	CLASS I	Intraocular lens recalled by Bausch & Lomb Surgical	Bausch & Lomb Surgical	Other	Nationwide
14 May 2025Device	CLASS I	Intraocular Lens recalled by Bausch & Lomb Surgical	Bausch & Lomb Surgical	Other	Nationwide
23 Apr 2025Device	CLASS II	Medline Convenience kits used for various procedures recalled	Medline Industries LP - Northfield	Sterility	Nationwide
2 Apr 2025Device	CLASS II	(Stenfilcon A) Contact Lens recalled by CooperVision	CooperVision	Mold	15 states
22 Jan 2025Device	CLASS II	Alcon Monarch¿ III D Delivery Cartridge recalled by Alcon Research	Alcon Research	Device Malfunction	42 states
30 Oct 2024Device	CLASS II	Medline medical procedure convenience kits, labeled as: EYE PACK recalled	Medline Industries LP - Northfield	Sterility	Nationwide
9 Oct 2024Device	CLASS II	Biofinity XR Toric Lenses - Soft Contact lenses Indicated recalled	CooperVision	Other	Nationwide
9 Oct 2024Device	CLASS II	Biofinity Toric Multifocal Lenses recalled by CooperVision	CooperVision	Other	Nationwide
2 Oct 2024Device	CLASS II	Custodiol HTK Solution recalled by Dr Franz Koehler Chemie	Dr Franz Koehler Chemie	Particulate Matter	Nationwide
24 Jan 2024Device	CLASS II	Tecnis Toric II OptiBlue IOL recalled by Johnson & Johnson Surgical	Johnson & Johnson Surgical Vision	Potency & Assay	CA
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO+Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states
13 Dec 2023Device	CLASS II	EVO +Visian Implantable Collamer Lens recalled by Staar Surgical	Staar Surgical	Device Malfunction	32 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.