Biofinity XR Toric Single Diagnostic lens- Soft recall
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Why was Biofinity XR Toric Single Diagnostic lens- Soft recalled?
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: N/A Lot Numbers: R24395839, R24406094, R24409954
- Product
- Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
- Recalling firm
- CooperVision, Inc.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of CA, OH, NC, PA.
- Recall date
- March 8, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)