Recall Z-1197-2023— CooperVision, Inc.

Name: FDA recall Z-1197-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-26

Class II · Ongoing

Class II FDA medical device recall by CooperVision, Inc., initiated 2023-01-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear). Reason: Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity.

Recalling firm: CooperVision, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-01-26
Firm location: West Henrietta, NY, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.