CooperVision, Inc. recalls BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with ast…

Recall date

August 29, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3310-2024

FDA classification

Class II

Brand / firm

CooperVision, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the country of Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.