West Henrietta, NY, United States
CooperVision Inc. recalls
12 recalls recorded since 2018, most recently on 12 August 2026. 8 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)8
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 12 August 2026
- Reason
- A small number of lenses within the affected lot are of the incorrect power.
- Distribution
- US Nationwide distribution in the states of MN, OH, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3248-2026
- Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
Ongoing Class II Medical devices
- Recall started
- 22 August 2025
- Reason
- One lot manufactured with an invalid sterilization cycle.
- Distribution
- US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2606-2025, Z-2608-2025, Z-2607-2025
- MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
- Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear.
- Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister package
Ongoing Class II Medical devices
- Recall started
- 16 June 2025
- Reason
- Lens blisters may have an incomplete or leaking seal which may render them unsterile.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2165-2025, Z-2166-2025
- Biofinity XR Toric Contact Lens
- Biofinity Toric Multifocal Contact Lens
Ongoing Class II Medical devices
- Recall started
- 27 February 2025
- Reason
- a limited number of lots were manufactured with an incorrect cylinder power.
- Distribution
- Domestic: CA, CO, FL, IL, KY, MI, NC, NE, NJ, NY, OH, OR, UT, VA, WA. International: Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Italy, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1455-2025
- Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Day Premium For Astigmatism, REVEAL 1-DAY TORIC, Vision Source Reveal Toric, Voyant 1-Day Premium To
Ongoing Class II Medical devices
- Recall started
- 29 August 2024
- Reason
- Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3311-2024, Z-3310-2024
- Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
- 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.
Ongoing Class II Medical devices
- Recall started
- 14 February 2023
- Reason
- The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and WI. The country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1282-2023
- Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
Ongoing Class II Medical devices
- Recall started
- 26 January 2023
- Reason
- Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
- Distribution
- US Nationwide distribution in the states of CA, OH, NC, PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1197-2023, Z-1198-2023
- Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
- Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Ongoing Class II Medical devices
- Recall started
- 27 December 2022
- Reason
- Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
- Distribution
- Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1014-2023
- MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
Terminated Class II Medical devices
- Recall started
- 19 May 2021
- Terminated
- 13 March 2023
- Reason
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, NY, TN, OH, NC, WI and the countries of France, United Arab Emirates, Brazil, Australia, New Zealand, Taiwan, Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2148-2021, Z-2144-2021, Z-2153-2021, Z-2150-2021, Z-2146-2021, Z-2147-2021, Z-2149-2021, Z-2151-2021, Z-2152-2021, Z-2154-2021, Z-2145-2021, Z-2143-2021
- SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
- AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
- FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
- CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
- CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
- CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
- CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
- MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
- and 4 more product lines
Terminated Class II Medical devices
- Recall started
- 13 January 2020
- Terminated
- 22 July 2020
- Reason
- Incorrect power of lenses than the expected
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1227-2020, Z-1228-2020
- Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
- Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
Terminated Class III Medical devices
- Recall started
- 21 February 2018
- Terminated
- 2 October 2019
- Reason
- The secondary packaging is labeled with an incorrect expiration date.
- Distribution
- US Nationwide Distribution to states of: AL, AR, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1516-2018, Z-1517-2018, Z-1515-2018, Z-1518-2018
- clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for dai
- 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wea
- clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicate
- 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wea
Terminated Class III Medical devices
- Recall started
- 1 September 2017
- Terminated
- 30 July 2018
- 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 correctly reads Biofinity XR Toric.
- Distribution
- USA Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0691-2018
- Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic an
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.