PlainRecalls
FDA Devices Moderate Class II Ongoing

Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)

Reported: March 8, 2023 Initiated: January 26, 2023 #Z-1198-2023

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

Details

Recalling Firm
CooperVision, Inc.
Units Affected
4 units
Distribution
US Nationwide distribution in the states of CA, OH, NC, PA.
Location
West Henrietta, NY

Frequently Asked Questions

What product was recalled?
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear). Recalled by CooperVision, Inc.. Units affected: 4 units.
Why was this product recalled?
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Which agency issued this recall?
This recall was issued by the FDA Devices on March 8, 2023. Severity: Moderate. Recall number: Z-1198-2023.