Contact Lenses & Eye Devices recalls

152 medical device recalls in the contact lenses & eye devices category are on file with the FDA, from 2013 to 1 Apr 2026.

Total recalls152since 2013

Last 12 months5reported

Class I43% of total

Ongoing49latest 1 Apr 2026

Recalls per month, last 24 months

click a bar for that month

4Oct '24 0 0 1Jan '25 0 0 2Apr 2 1 2Jul 0 1 3Oct 1 0 0Jan '26 0 0 1Apr 0 0 0Jul 0 0

Severity split

Class I 4 3%Class II 140 92%Class III 8 5%

Why contact lenses & eye devices is recalled

Companies

By year

202611%
2025139%
202453%
20231812%
202243%
20211611%
20201510%
201932%
2018128%
201764%

Ongoing contact lenses & eye devices recalls

49 active

Reported	Class	Recall	Company	Reason	Where
1 Apr 2026Device	CLASS II	Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled	AMO Puerto Rico Manufacturing	Sterility	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	Mold	Nationwide
1 Oct 2025Device	CLASS II	Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled	CooperVision	Mold	Nationwide
1 Oct 2025Device	CLASS II	MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision	CooperVision	Mold	Nationwide
3 Sep 2025Device	CLASS III	Akreos, SKU: AO60P0300. Akreos intraocular lenses recalled	Bausch & Lomb Surgical	Other	AZ, CA

All contact lenses & eye devices recalls, newest first

152 total

Reported	Class	Recall	Company	Reason	Where
1 Apr 2026Device	CLASS II	Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled	AMO Puerto Rico Manufacturing	Sterility	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	Mold	Nationwide
1 Oct 2025Device	CLASS II	Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled	CooperVision	Mold	Nationwide
1 Oct 2025Device	CLASS II	MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision	CooperVision	Mold	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	Sterility	Nationwide
30 Jul 2025Device	CLASS II	Biofinity XR Toric Contact Lens recalled by CooperVision	CooperVision	Sterility	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

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.