CooperVision, Inc. Recall 91607
Description: Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
CooperVision, Inc. Recall 91607 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1197-2023 |
| Event ID | 91607 |
| Event Description | Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear) |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, OH, NC, PA. |
| Quantity | 24 units |
| Recall Reason | Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity |
| Device Classification | 20230308 |
| Device Code Info | UDI: N/A Lot Numbers: R24377024, R24377026, R24381716, R24416900 |
| Center Classification Date | 20230301 |
| Recall Initiation Date | 20230126 |
| Recalling Firm | CooperVision, Inc. |
| Initial Notification | Letter |
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