Z-1198-2023 Class II Ongoing
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
- 4 units
Product Description
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
Distribution Pattern
US Nationwide distribution in the states of CA, OH, NC, PA.
Code Information
UDI: N/A Lot Numbers: R24395839, R24406094, R24409954