FDA Medical devices recall ·
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recall
- Recall number
- Z-2608-2025
- Date
- (initiated August 22, 2025)
- Company / brand
- CooperVision, Inc.
180 Thruway Park Dr, West Henrietta, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 90 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Why was it recalled?
One lot manufactured with an invalid sterilization cycle.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898.
Distribution
US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
States: Florida Kentucky North Carolina Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2608-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.