CooperVision recalled 180 units of Sofmed Breathables contact lenses on August 22, 2025. The recall affects one lot manufactured with an invalid sterilization cycle. Patients and healthcare providers must stop using the affected lenses immediately.
One lot manufactured with an invalid sterilization cycle.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CooperVision, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
The recalled product is Sofmed Breathables contact lenses, model number Softmed Breathables. They contain 54% water and are made from toric, cast-moulded silicone hydrogel. The affected lot includes carton lot number 20735504301008 and blister lot number 6450505898.
The recall involves lenses from a lot that failed to undergo proper sterilization, posing a risk of infection or other serious eye conditions. This issue falls under Class II classification, indicating a potential for temporary or medically reversible health consequences.
As of the latest report, there are no injuries or infections linked to this recall. Consumers are urged to return the product as a precaution.
Patients and healthcare providers should stop using the affected contact lenses immediately. For instructions, contact CooperVision or your healthcare provider. Follow the recall instructions provided via email, fax, letter, or phone.
For further information, contact CooperVision at the customer service number provided in the recall notification. More details can be found at the FDA's website.
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