Class II — CooperVision, Inc.
| Recalling firm | COOPERVISION, INC. |
|---|---|
| Registered facility | View this company's 14 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity |
| Product | Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear) |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of CA, OH, NC, PA. |
| Initiated | 2023-01-26 |
| Classified | 2023-03-01 |
| Recall number | Z-1198-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CooperVision, Inc. (Z-1198-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91607/
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