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CooperVision, Inc.

21 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water cont recall (Z-2606-2025)CooperVision, Inc.2025-09-19
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% wa recall (Z-2607-2025)CooperVision, Inc.2025-09-19
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premiu recall (Z-2608-2025)CooperVision, Inc.2025-09-19
Biofinity XR Toric Contact Lens recall (Z-2165-2025)CooperVision, Inc.2025-07-23
Biofinity Toric Multifocal Contact Lens recall (Z-2166-2025)CooperVision, Inc.2025-07-23
Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For recall (Z-1455-2025)CooperVision, Inc.2025-03-26
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia recall (Z-3310-2024)CooperVision, Inc.2024-09-30
Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of am recall (Z-3311-2024)CooperVision, Inc.2024-09-30
Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90 recall (Z-1282-2023)CooperVision, Inc.2023-03-23
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) recall (Z-1197-2023)CooperVision, Inc.2023-03-01
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear) recall (Z-1198-2023)CooperVision, Inc.2023-03-01
MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily recall (Z-1014-2023)CooperVision, Inc.2023-01-24
Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact recall (Z-1227-2020)CooperVision Inc.2020-01-27
Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydrophilic) Contact recall (Z-1228-2020)CooperVision Inc.2020-01-27
Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx recall (Z-0542-2014)CooperVision Inc.2013-12-19
ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmati recall (Z-0543-2014)CooperVision Inc.2013-12-19
AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses (disposab recall (Z-0350-2012)Coopervision Inc.2012-01-11
AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES F recall (Z-0044-2012)CooperVision Inc.2011-10-14
ClearSight(TM) 1-Day (ocufilcon D) Toric 30 daily disposable contact lenses for astigmatis recall (Z-0125-2010)CooperVision Inc.2009-11-09
Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible fir recall (Z-1091-03)Coopervision Inc2003-08-07
SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (me recall (Z-0978-03)Coopervision Inc2003-07-03

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Every clearance here is in the API, with alerts when new ones post.