CooperVision MyDay Toric contact lenses recalled for invalid sterilization
CooperVision is recalling one lot of MyDay Toric contact lenses distributed in four U.S. states. One manufacturing lot was processed with an invalid sterilization cycle, which could affect product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for a risk-of-harm product (contact lenses with failed sterilization) where contamination or infection could occur. No illnesses or injuries have been reported.
Plain-English summary
CooperVision, Inc. is recalling one lot of MyDay Toric contact lenses due to invalid sterilization during manufacturing. MyDay Toric are daily disposable silicone hydrogel contact lenses designed for toric (astigmatism) correction.
The affected lot (Carton Lot Number 20735504301008, Blister Lot Number 6450505898) consists of 4,140 units distributed in Florida, Kentucky, North Carolina, and Wisconsin. This lot was manufactured with an invalid sterilization cycle.
Consumers who have purchased contact lenses from the affected lot should stop using them and consult their eye care provider for replacement or alternative products. Contact lenses not properly sterilized may pose a risk of contamination or infection.
The recalled product
- 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.
- Manufacturer
- CooperVision, Inc.
- Category
- Medical Device — Contact Lenses
- Hazard
- sterilization-failure
- contamination-risk
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898
Distribution
Distributed nationwide across the United States.
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