Recall Z-0204-2027— CooperVision, Inc.
Class II · Ongoing
Class II FDA medical device recall by CooperVision, Inc., initiated 2026-09-22. It names 3 FDA 510(k) clearances: K220070, K213164, K160803. 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 packaged.. Reason: 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..
- Recalling firm
- CooperVision, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-09-22
- 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
- K213164 — Avaira Vitality
- K160803 — Avaira Vitality (fanfilcon A) Soft (Hydrofilic) 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
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 packaged.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.