Reported Mar 8, 2023 · Ongoing

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

CooperVision, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CooperVision, Inc. · 180 Thruway Park Dr · West Henrietta, NY · 14586-9798

Is this the product you have?

  • Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Lot codes and dates
  • UDIN/A
  • Lot Numbers
    • R24395839
    • R24406094
    • R24409954
Amount recalled
4 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:55 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.