Biofinity XR Toric Single Diagnostic lens- Soft — Class II medical device recall Z-1198-2023
Ongoing recall by CooperVision, Inc., reported 2023-03-08, distributed nationwide. Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visu
| Recall number | Z-1198-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperVision, Inc., West Henrietta, NY, United States |
| Recall initiated | 2023-01-26 |
| Classified | 2023-03-01 |
| Reported by FDA | 2023-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| Lot numbers | R24395839, R24406094, R24409954 |
Product
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Reason for recall
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1198-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.