Recall Z-2608-2025— CooperVision, Inc.
Class II · Ongoing
Class II FDA medical device recall by CooperVision, Inc., initiated 2025-08-22. It names 3 FDA 510(k) clearances: K220070, K190965, K131378. 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.. Reason: One lot manufactured with an invalid sterilization cycle..
- Recalling firm
- CooperVision, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-22
- Firm location
- West Henrietta, NY, United States
510(k) clearances named in this recall
3 on FDA's record- K220070 — MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
- K190965 — MyDay
- K131378 — SUS (STENFILCON A) CONTACT LENS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
One lot manufactured with an invalid sterilization cycle.
Data sourced from openFDA. This site is unofficial and independent of the FDA.