FDAAugust 29, 2024device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Manufactured with a misaligned axis resulting in lenses with the incorrect power, may experience poor visual acuity
What to do
FDA enforcement status: Ongoing
Brands named
coopervision
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASofmed 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.2025-08-22
- FDAVoyant 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.2025-08-22
- FDAMyDay 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.2025-08-22
- FDABiofinity XR Toric Contact Lens2025-06-16
- FDABiofinity Toric Multifocal Contact Lens2025-06-16
- FDABrand 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 OXYGE...2025-02-27
- FDABiofinity 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.2024-08-29
- FDAClariti 1-day toric soft contact lenses, Power -1.00 -1.25/902023-02-14
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