FDA Device recall Z-1198-2023
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
- FDA Device
- Class II
- ongoing
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class II recall of Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear) by Coopervision, citing manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1198-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-26 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coopervision |
| Distribution | US |
Product
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Reason
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Identifiers
| code_info | UDI: N/A Lot Numbers: R24395839, R24406094, R24409954 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Coopervision
- Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
FDA Device · Class II · 2026-09-30 · Coopervision - Sofmed Breathables, (stenfilcon A) contact lens
FDA Device · Class II · 2025-10-01 · Coopervision - Voyant 1-Day Premium Toric, (stenfilcon A) contact lens
FDA Device · Class II · 2025-10-01 · Coopervision - MyDay Toric, stenfilcon A) Contact Lens
FDA Device · Class II · 2025-10-01 · Coopervision - Biofinity XR Toric Contact Lens
FDA Device · Class II · 2025-07-30 · Coopervision
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1198-2023%22
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