CooperVision Inc.: 33 FDA recall reports
Every medical device recall the FDA has published for CooperVision Inc.. The fault, and how the agency graded it.
33Reports
0Class I
12Ongoing
2025-10-01Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast
Z-2606-2025 · Class II · reported 2025-10-01 · Ongoing
- Why it was recalled
- One lot manufactured with an invalid sterilization cycle.
- Product
- 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.
- Where it went
- US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
- How much
- 4,140 units
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% wate
Z-2608-2025 · Class II · reported 2025-10-01 · Ongoing
- Why it was recalled
- One lot manufactured with an invalid sterilization cycle.
- Product
- 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. Blister packaged.
- Where it went
- US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
- How much
- 90 units
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Tori
Z-2607-2025 · Class II · reported 2025-10-01 · Ongoing
- Why it was recalled
- One lot manufactured with an invalid sterilization cycle.
- Product
- 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 packaged.
- Where it went
- US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
- How much
- 180 units
Biofinity XR Toric Contact Lens
Z-2165-2025 · Class II · reported 2025-07-30 · Ongoing
- Why it was recalled
- Lens blisters may have an incomplete or leaking seal which may render them unsterile.
- Product
- Biofinity XR Toric Contact Lens
- Where it went
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
- How much
- 397 units
Biofinity Toric Multifocal Contact Lens
Z-2166-2025 · Class II · reported 2025-07-30 · Ongoing
- Why it was recalled
- Lens blisters may have an incomplete or leaking seal which may render them unsterile.
- Product
- Biofinity Toric Multifocal Contact Lens
- Where it went
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Honduras, and Mexico.
- How much
- 827 units
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle
Z-1455-2025 · Class II · reported 2025-04-02 · Ongoing
- Why it was recalled
- a limited number of lots were manufactured with an incorrect cylinder power.
- Product
- 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 Toric. Brand Names (OUS only): CADENCE DELUXE 1-DAY TORIC, DUBLAN PREMIUM OXYGEN 1 DAY TORIC, EV LINARIAL TORIC (30), EYEXPERT PURE ASTIGMATISM (30), LENTI!!AS A ASTIGMATISMO 30PK, LENTSOFT DIARIA CONFORT+ SILICONA ASTIGMATISMO, MULTILENS CONTACT ELITE SILICONE 1 DAY TORICS, OPTIONS SUPREME 1 DAY TRC (30), PRIMA + 1 DAY ASTGM (30), PROTECT PLATINUM FOR ASTG (30), SOL- LENS 1 DAY SILICONE PREMIUM TORIC, UGO LENS DAY ADVANCED TORICA, WHITE BOX STENFILCON A TORIC 07536, MEDIFLEX SUP 1D TORIC, Kirkland Signature Toric Premium Daily Disposable, Specsavers easyvision Linarial Toric. Product Name: (Stenfilcon A) Contact Lens Model/Catalog Number: MyDay Toric Product Description: 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged. Component: No
- Where it went
- 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.
- How much
- 33990 lenses (17010 US, 16980 OUS)
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or h
Z-3311-2024 · Class II · reported 2024-10-09 · Ongoing
- Why it was recalled
- Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
- Product
- 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.
- Where it went
- Worldwide distribution - US Nationwide and the country of Canada.
- How much
- 2443 lenses
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia
Z-3310-2024 · Class II · reported 2024-10-09 · Ongoing
- Why it was recalled
- Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
- Product
- 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.
- Where it went
- Worldwide distribution - US Nationwide and the country of Canada.
- How much
- 607 lenses
Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
Z-1282-2023 · Class II · reported 2023-03-29 · Ongoing
- Why it was recalled
- The lenses manufactured in the affected lot were made with a misaligned axis resulting in lenses with the incorrect power.
- Product
- Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
- Where it went
- Worldwide - US Nationwide distribution in the states of FL, IL, NY, UT, and WI. The country of Canada.
- How much
- 3150
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Z-1197-2023 · Class II · reported 2023-03-08 · Ongoing
- Why it was recalled
- Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
- Product
- Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
- Where it went
- US Nationwide distribution in the states of CA, OH, NC, PA.
- How much
- 24 units
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Z-1198-2023 · Class II · reported 2023-03-08 · Ongoing
- Why it was recalled
- Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
- Product
- Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
- Where it went
- US Nationwide distribution in the states of CA, OH, NC, PA.
- How much
- 4 units
MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Us
Z-1014-2023 · Class II · reported 2023-02-01 · Ongoing
- Why it was recalled
- Lenses may be of the incorrect power. A patient who uses an affected lens may experience poor visual acuity.
- Product
- MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
- Where it went
- Distribution to US states of CA, FL, IA, KY, NC, NY, OH, OR, WI; Canada and Japan.
- How much
- 6,570 lenses
SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
Z-2148-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Product
- SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
- Where it went
- 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.
- How much
- 60 lenses
AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
Z-2144-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Product
- AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
- Where it went
- 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.
- How much
- 720 lenses
FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
Z-2153-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Product
- FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
- Where it went
- 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.
- How much
- 180 lenses
CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Z-2150-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Product
- CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
- Where it went
- 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.
- How much
- 450 lenses
CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Z-2146-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Product
- CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
- Where it went
- 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.
- How much
- 90 lenses
CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
Z-2147-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Product
- CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
- Where it went
- 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.
- How much
- 1260 lenses
CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Z-2149-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Product
- CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
- Where it went
- 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.
- How much
- 10 lenses
MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
Z-2151-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Product
- MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
- Where it went
- 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.
- How much
- 90 lenses
CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
Z-2152-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Product
- CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
- Where it went
- 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.
- How much
- 450 lenses
SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker
Z-2154-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Product
- SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker
- Where it went
- 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.
- How much
- 90 lenses
FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
Z-2145-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Product
- FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
- Where it went
- 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.
- How much
- 90 lenses
CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
Z-2143-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Misaligned placement of an axis mark can cause the patient to experience blurred vision
- Product
- CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
- Where it went
- 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.
- How much
- 90 lenses
Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended we
Z-1227-2020 · Class II · reported 2020-02-19 · Terminated
- Why it was recalled
- Incorrect power of lenses than the expected
- Product
- Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
- Where it went
- US Nationwide Distribution
- How much
- 216 units
Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended we
Z-1228-2020 · Class II · reported 2020-02-19 · Terminated
- Why it was recalled
- Incorrect power of lenses than the expected
- Product
- Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact Lens (extended wear)
- Where it went
- US Nationwide Distribution
- How much
- 24
clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clar
Z-1516-2018 · Class III · reported 2018-05-02 · Terminated
- Why it was recalled
- The secondary packaging is labeled with an incorrect expiration date.
- Product
- 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 daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
- Where it went
- 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.
- How much
- 32 packs/2880 lenses
56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1
Z-1517-2018 · Class III · reported 2018-05-02 · Terminated
- Why it was recalled
- The secondary packaging is labeled with an incorrect expiration date.
- Product
- 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 wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
- Where it went
- 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.
- How much
- 328 packs/3280 lenses
clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses
Z-1515-2018 · Class III · reported 2018-05-02 · Terminated
- Why it was recalled
- The secondary packaging is labeled with an incorrect expiration date.
- Product
- 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 indicated for daily wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
- Where it went
- 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.
- How much
- 22 packs/1980 lenses
56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1
Z-1518-2018 · Class III · reported 2018-05-02 · Terminated
- Why it was recalled
- The secondary packaging is labeled with an incorrect expiration date.
- Product
- 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 wear single use only for the correction of refractiveametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Dopters that does not interfere with visualacuity. Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UVblocker help protect against transmission of harmful UV radiation to the cornea andinto the eye.
- Where it went
- 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.
- How much
- 105 packs/1050 lenses
Showing the 30 most recent of 33. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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