Z-1197-2023 Class II Ongoing
FDA device recall Z-1197-2023 was initiated by CooperVision, Inc. on January 26, 2023 and is designated Class II. Reason for recall: Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity The recall status is ongoing. Affected quantity: 24 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2023
- Initiation Date
- January 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
Biofinity XR Toric 6-pack- 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
Distribution Pattern
US Nationwide distribution in the states of CA, OH, NC, PA.
Code Information
UDI: N/A Lot Numbers: R24377024, R24377026, R24381716, R24416900