Coopervision recalls
Coopervision appears in 34 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-30.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 34 |
|---|---|
| Published | 2013-12-25 to 2026-09-30 |
| By agency | FDA Device (34) |
| By classification | Class II (29), Class III (5) |
| By status | terminated (21), ongoing (13) |
| Distribution named in notices | CA, CO, FL, IA, IL, KY, MI, NC, NE, NJ, NY, OH, OR, US, UT, VA, WA, WI |
Recalls
- Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
FDA Device · Class II · 2026-09-30 · Coopervision
Reason: A small number of lenses within the affected lot are of the incorrect power. - Sofmed Breathables, (stenfilcon A) contact lens
FDA Device · Class II · 2025-10-01 · Coopervision
Reason: One lot manufactured with an invalid sterilization cycle. - Voyant 1-Day Premium Toric, (stenfilcon A) contact lens
FDA Device · Class II · 2025-10-01 · Coopervision
Reason: One lot manufactured with an invalid sterilization cycle. - MyDay Toric, stenfilcon A) Contact Lens
FDA Device · Class II · 2025-10-01 · Coopervision
Reason: One lot manufactured with an invalid sterilization cycle. - Biofinity XR Toric Contact Lens
FDA Device · Class II · 2025-07-30 · Coopervision
Reason: Lens blisters may have an incomplete or leaking seal which may render them unsterile. - Biofinity Toric Multifocal Contact Lens
FDA Device · Class II · 2025-07-30 · Coopervision
Reason: Lens blisters may have an incomplete or leaking seal which may render them unsterile. - Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Ast…
FDA Device · Class II · 2025-04-02 · Coopervision
Reason: a limited number of lots were manufactured with an incorrect cylinder power. - BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presb…
FDA Device · Class II · 2024-10-09 · Coopervision
Reason: Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity - Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) wi…
FDA Device · Class II · 2024-10-09 · Coopervision
Reason: Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity - Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
FDA Device · Class II · 2023-03-29 · Coopervision
Reason: The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power. - Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
FDA Device · Class II · 2023-03-08 · Coopervision
Reason: Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity - Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
FDA Device · Class II · 2023-03-08 · Coopervision
Reason: Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity - MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear)
FDA Device · Class II · 2023-02-01 · Coopervision
Reason: Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity. - CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision
Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision - CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision
Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision - CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision
Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision - CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision
Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision - AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision
Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision - CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision
Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision - FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision
Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision - CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision
Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision - FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision
Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision - SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision
Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision - MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision
Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision - SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker
FDA Device · Class II · 2021-08-04 · Coopervision
Reason: Misaligned placement of an axis mark can cause the patient to experience blurred vision - Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
FDA Device · Class II · 2020-02-19 · Coopervision
Reason: Incorrect power of lenses than the expected - Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
FDA Device · Class II · 2020-02-19 · Coopervision
Reason: Incorrect power of lenses than the expected - clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hy…
FDA Device · Class III · 2018-05-02 · Coopervision
Reason: The secondary packaging is labeled with an incorrect expiration date. - clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A)…
FDA Device · Class III · 2018-05-02 · Coopervision
Reason: The secondary packaging is labeled with an incorrect expiration date. - 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophil…
FDA Device · Class III · 2018-05-02 · Coopervision
Reason: The secondary packaging is labeled with an incorrect expiration date. - 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophil…
FDA Device · Class III · 2018-05-02 · Coopervision
Reason: The secondary packaging is labeled with an incorrect expiration date. - Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the c…
FDA Device · Class III · 2018-03-07 · Coopervision
Reason: The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity XR Toric blister labels. The primary blister reads Biofinity Multifocal Toric in error, and should read Biofinity XR Toric. The outer carton c… - ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO3…
FDA Device · Class II · 2013-12-25 · Coopervision
Reason: Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date. - Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - S…
FDA Device · Class II · 2013-12-25 · Coopervision
Reason: Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.