FDA-Device2023-03-08Class II
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
CooperVision, Inc.
Hazard
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
Sold states
US Nationwide distribution in the states of CA, OH, NC, PA.
Affected count
4 units
Manufactured in
180 Thruway Park Dr, N/A, West Henrietta, NY, United States
Products
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1198-2023Don't want to check this manually?
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