Clerio Vision product recalled over labeling errors

Recall date

February 16, 2021

Source

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

Official notice title

Clerio Vision recalls EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correctio…

Recall number

Z-1352-2021

FDA classification

Class II

Brand / firm

Clerio Vision

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of Illinois and Missouri, and the countries of Denmark, Germany, The Netherlands, Switzerland.

Why it was recalled

Contact lenses may be mislabeled with the incorrect lens power.

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

What was recalled

EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.