Sofmed Breathables contact lens recall due to invalid sterilization cycle
CooperVision is recalling one lot of Sofmed Breathables contact lenses due to manufacturing with an invalid sterilization cycle. The affected lenses may not be properly sterilized and could pose a risk to eye health.
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: This is an FDA Class II recall involving contact lenses with an invalid sterilization cycle. No illnesses or injuries are reported in the recall notice, but improperly sterilized contact lenses pose an inherent risk of eye infection when worn.
Plain-English summary
CooperVision, Inc. is recalling one lot of Sofmed Breathables contact lenses due to a manufacturing defect. The lot was manufactured with an invalid sterilization cycle, meaning the lenses may not be properly sterilized before use.
Contact lenses must be properly sterilized to prevent microbial contamination. If lenses are not properly sterilized, they may harbor bacteria or other organisms that could cause eye infections when worn.
The affected lot can be identified by Carton Lot Number 20735504301008 and Blister Lot Number 6450505898. The lot consists of 180 units and has been distributed nationwide, including the states of Florida, Kentucky, North Carolina, and Wisconsin.
Consumers who possess lenses from this lot should stop using them immediately and contact CooperVision or their eye care provider for guidance on obtaining replacement lenses or alternative products.
The recalled product
- 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.
- Manufacturer
- CooperVision, Inc.
- Category
- Medical Device — Contact Lenses
- Hazard
- sterilization-failure
- 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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