CooperVision recalled 4,140 units of MyDay Toric contact lenses on August 22, 2025, due to an invalid sterilization cycle. The recall affects lenses distributed nationwide, particularly in Florida, Kentucky, North Carolina, and Wisconsin. Users must stop using these lenses immediately to avoid potential health risks.
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 the MyDay Toric contact lens, made from stenfilcon A silicone hydrogel with 54% water content. The affected carton lot number is 20735504301008, and the blister lot number is 6450505898. These lenses were distributed across multiple states in the U.S.
The recall stems from a manufacturing error where one lot of lenses was produced with an invalid sterilization cycle. This could potentially expose users to harmful bacteria or other pathogens.
No injuries have been reported at this time. However, the high hazard level indicates a significant risk of eye infections or other complications.
Patients and healthcare providers should stop using the MyDay Toric contact lenses immediately. Follow the manufacturer's recall instructions and contact CooperVision, Inc. or your healthcare provider for further guidance.
For more information, reach CooperVision at the following link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-2606-2025.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.