# Class II recall Z-0204-2027: CooperVision, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0204-2027 |
| Recalling firm | CooperVision, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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. |
| Quantity | 230856 |
| Distribution | US Nationwide distribution in the states of FL, KY, MI. |
| Recall initiated | 2026-09-22 |
| Reported | 2026-10-28 |
| Firm location | West Henrietta, NY, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 8 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0204-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.