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CooperVision, Inc. FDA Recalls
25 recalls on file across devices, 0 of them Class I and 13 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 dayClass IIAug 12, 2026A small number of lenses within the affected lot are of the |
| MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded SiClass IIAug 22, 2025One lot manufactured with an invalid sterilization cycle. |
| Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moClass IIAug 22, 2025One lot manufactured with an invalid sterilization cycle. |
| Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content,Class IIAug 22, 2025One lot manufactured with an invalid sterilization cycle. |
| Biofinity Toric Multifocal Contact LensClass IIJun 16, 2025Lens blisters may have an incomplete or leaking seal which m |
| Biofinity XR Toric Contact LensClass IIJun 16, 2025Lens blisters may have an incomplete or leaking seal which m |
| Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism, Pearle Vision 1 Class IIFeb 27, 2025a limited number of lots were manufactured with an incorrect |
| BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astiClass IIAug 29, 2024Manufactured with a misaligned axis resulting in lenses with |
| Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia wClass IIAug 29, 2024Manufactured with a misaligned axis resulting in lenses with |
| Clariti 1-day toric soft contact lenses, Power -1.00 -1.25/90Class IIFeb 14, 2023The lenses manufactured in the affected lot were made with a |
| Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)Class IIJan 26, 2023Manufactured with misaligned axis resulting in lenses with |
| Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)Class IIJan 26, 2023Manufactured with misaligned axis resulting in lenses with |
| MyDay Toric (90-pack) Reveal 1 Day Toric (90-pack) Soft (hydrophilic) Contact Lens (daily wear). Single Use.Class IIDec 27, 2022Lenses may be of the incorrect power. A patient who uses an |
| FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with UV blockerClass IIMay 19, 2021Misaligned placement of an axis mark can cause the patient t |
| CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blockerClass IIMay 19, 2021Misaligned placement of an axis mark can cause the patient t |
| CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blockerClass IIMay 19, 2021Misaligned placement of an axis mark can cause the patient t |
| AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blockerClass IIMay 19, 2021Misaligned placement of an axis mark can cause the patient t |
| FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with UV blockerClass IIMay 19, 2021Misaligned placement of an axis mark can cause the patient t |
| CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blockerClass IIMay 19, 2021Misaligned placement of an axis mark can cause the patient t |
| CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with UV blockerClass IIMay 19, 2021Misaligned placement of an axis mark can cause the patient t |
| SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact Lens with UV blockerClass IIMay 19, 2021Misaligned placement of an axis mark can cause the patient t |
| CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact Lens with UV blockerClass IIMay 19, 2021Misaligned placement of an axis mark can cause the patient t |
| CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blockerClass IIMay 19, 2021Misaligned placement of an axis mark can cause the patient t |
| MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with UV blockerClass IIMay 19, 2021Misaligned placement of an axis mark can cause the patient t |
| SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with UV blockerClass IIMay 19, 2021Misaligned placement of an axis mark can cause the patient t |