The Recall Desk

Manufacturer

CooperVision, Inc.

33 recalls in our database name CooperVision, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
33
Critical
0
Severe
0
Most recent
2025-10-01

Of the 33 recalls from CooperVision, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 33

  • HighFDA (Devices)·Z-2606-2025·2025-10-01

    MyDay toric contact lenses recalled after one lot used invalid sterilization

    MyDay Toric contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 4,140 units are affected.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2608-2025·2025-10-01

    Voyant daily toric contact lenses recalled over an invalid sterilization cycle

    Voyant 1-Day Premium Toric contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 90 units are affected.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2607-2025·2025-10-01

    Sofmed Breathables contact lenses recalled over an invalid sterilization cycle

    Sofmed Breathables contact lenses from one lot are recalled because the lot was manufactured with an invalid sterilization cycle. 180 units are affected.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2165-2025·2025-07-30

    Biofinity XR Toric contact lens blisters may have a leaking seal

    Biofinity XR Toric Contact Lenses are being recalled because lens blisters may have an incomplete or leaking seal, which may render them unsterile. 397 units are affected.

    Product
    Biofinity XR Toric Contact Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2025·2025-07-30

    Biofinity Toric Multifocal contact lens blisters may have a leaking seal

    Biofinity Toric Multifocal Contact Lenses are being recalled because lens blisters may have an incomplete or leaking seal, which may render them unsterile. 827 units are affected.

    Product
    Biofinity Toric Multifocal Contact Lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2025·2025-04-02

    Contact lenses for astigmatism recalled due to incorrect cylinder power

    CooperVision is recalling multiple brands of daily disposable toric contact lenses manufactured with incorrect cylinder power in certain lot codes. Users of affected lenses should stop wearing them and contact their eye care provider.

    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, DUB
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-3311-2024·2024-10-09

    Contact lenses with misaligned axis may cause poor visual acuity

    CooperVision is recalling Biofinity Toric Multifocal soft contact lenses manufactured with misaligned axes resulting in incorrect optical power. Affected lenses may cause 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3310-2024·2024-10-09

    BIOFINITY XR TORIC Contact Lenses Recalled for Misaligned Axis Defect

    CooperVision is recalling 607 BIOFINITY XR TORIC soft contact lenses due to a manufacturing defect with misaligned axis, resulting in incorrect power and poor visual acuity. The lenses were distributed in the US and Canada.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1282-2023·2023-03-29

    Contact Lens Recall: CooperVision Clariti 1-day Toric With Incorrect Power

    CooperVision is recalling Clariti 1-day toric contact lenses from lot W0124677 because they were made with a misaligned axis that results in incorrect lens power.

    Product
    Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1198-2023·2023-03-08

    CooperVision Biofinity XR Toric lenses recalled for manufacturing misalignment

    CooperVision is recalling Biofinity XR Toric contact lenses manufactured with misaligned axis, resulting in incorrect lens power and poor visual acuity.

    Product
    Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1197-2023·2023-03-08

    Contact Lenses Recalled for Misaligned Axis Causing Poor Vision

    CooperVision is recalling Biofinity XR Toric contact lenses due to misaligned axis in manufacturing that results in incorrect lens power. Users may experience poor visual acuity.

    Product
    Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2023·2023-02-01

    MyDay Toric and Reveal 1 Day Toric Contact Lenses Recalled for Incorrect Power

    CooperVision is recalling MyDay Toric and Reveal 1 Day Toric contact lenses because some may have incorrect power, resulting in poor visual acuity. Consumers using affected lots should stop wearing the lenses and consult their eye care provider.

    Product
    MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2143-2021·2021-08-04

    Contact Lens Recall: Misaligned Axis Mark May Cause Blurred Vision

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses with misaligned axis marks that may cause blurred vision. The defective lenses were distributed worldwide including multiple U.S. states.

    Product
    CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2021·2021-08-04

    Contact Lens Recall: Misaligned Axis Mark May Cause Blurred Vision

    CooperVision is recalling SPECSAVERS UMERE TORIC daily disposable contact lenses with UV blocker due to a manufacturing defect in which misaligned axis marks may cause blurred vision.

    Product
    SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2144-2021·2021-08-04

    Contact Lens Axis Mark Misalignment May Cause Blurred Vision

    CooperVision's AQUATECH PLUS 1 DAY TORIC contact lenses (lot R0121629) have misaligned axis marks that may cause blurred vision in patients.

    Product
    AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2150-2021·2021-08-04

    Contact lens recall: misaligned axis mark may cause blurred vision

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that may cause blurred vision. The recall affects 450 lenses distributed across select U.S. states and multiple countries.

    Product
    CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2146-2021·2021-08-04

    CooperVision CLARITI 1 DAY TORIC contact lenses recalled for axis mark misalignment

    CooperVision is recalling CLARITI 1 DAY TORIC daily disposable contact lenses due to misaligned axis marks that can cause blurred vision. Affected lenses in lot U0108833 were distributed in seven US states and internationally.

    Product
    CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2149-2021·2021-08-04

    CLARITI 1 DAY TORIC Contact Lenses Recalled Due to Axis Mark Misalignment

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that can cause blurred vision. Affected patients should discontinue use and contact their eye care provider.

    Product
    CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2021·2021-08-04

    CooperVision Contact Lenses Recalled for Misaligned Axis Mark

    CooperVision is recalling MEDIFLEX ELITE 1 DAY TORIC daily disposable contact lenses (lot W0106167) due to misaligned axis marks that can cause blurred vision.

    Product
    MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2021·2021-08-04

    Daily Toric Contact Lenses Recalled for Misaligned Axis Mark

    CooperVision is recalling SOFMED BREATHABLES 1 DAY TORIC contact lenses (Lot W0106167) due to misaligned axis marks that can cause blurred vision. Affected lenses were distributed in the US and internationally.

    Product
    SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2021·2021-08-04

    CooperVision CLARITI Contact Lenses Recalled for Misaligned Axis Marks

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot U0108940) because misaligned axis marks can cause blurred vision in patients.

    Product
    CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2021·2021-08-04

    Contact lens recall due to misaligned axis marking

    CooperVision Inc. is recalling FRESH DAY 1 DAY TORIC contact lenses (Lot R0121629) due to misaligned axis marks that may cause blurred vision in wearers.

    Product
    FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2153-2021·2021-08-04

    Contact Lens Axis Mark Misalignment Causes Blurred Vision

    CooperVision's FRESH DAY 1 DAY TORIC contact lenses (lot W0106186) are recalled because misaligned axis marks can cause blurred vision. Affected lenses were distributed worldwide, including in the US, France, Brazil, and other countries.

    Product
    FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2152-2021·2021-08-04

    CooperVision CLARITI 1 DAY TORIC contact lenses recalled for axis misalignment

    CooperVision is recalling CLARITI 1 DAY TORIC contact lenses (Lot W0106186) due to misaligned placement of the axis mark, which can cause blurred vision.

    Product
    CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blocker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1227-2020·2020-02-19

    CooperVision Vertex Toric Contact Lenses Recalled for Incorrect Power

    CooperVision is recalling 216 units of Vertex Toric contact lenses because they have an incorrect power than expected.

    Product
    Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear)
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

CooperVision

company in Fairport, United States

Country
United States
Founded
1958
Parent company
The Cooper Companies

Official website

Source: Wikidata (Q15030582), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.