CooperVision recalls Softmed Breathables Advanced Toric contact lenses for labeling error
CooperVision is recalling Softmed Breathables Advanced Toric contact lenses because the packaging incorrectly states they are for extended wear, though they are only approved for daily wear.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall addresses a labeling error where the packaging incorrectly indicates the lenses are for extended wear, despite being approved only for daily wear. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
CooperVision, Inc. is recalling Softmed Breathables Advanced Toric (fanfilcon A) soft contact lenses. The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear." However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use.
The recall involves 230,856 units of the product. The affected units were distributed nationwide in the states of Florida, Kentucky, and Michigan. The recall is classified as Class II by the FDA.
Consumers should stop using the affected contact lenses and contact their eye care professional or CooperVision for further instructions.
The recalled product
- Product
- Generic Name: Softmed Breathables Advanced Toric (fanfilcon A) Soft (Hydrophilic) Contact Lens; Model/Catalog Number: Softmed Breathables Advanced Toric Product Description: 55% water content, toric, silicone hydrogel contact lens for daily wear, frequent replacement. Blister…
- Manufacturer
- CooperVision, Inc.
- Category
- Medical Device — Contact Lenses
- Hazard
- Affected units
- 230,856
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 (20)
- Model/Catalog Number: Softmed Breathables Advanced Toric
- UDI-DI: N/A Lot numbers: 19486120027517
- 19486120030515
- 19486120035532
- 19486120051506
- 19486170015507
- 19486170016513
- 19486170016521
- 19486170017507
- 19486170017509
- 19486170017512
- 19486170019512
- 19486170019514
- 19486170021021
- 19486170021518
- 19486170022503
- 19486170022504
- 19486170023528
- 19486170025508
- 19486170026021
Distribution
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