Alden Optical recalls Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The ALDEN SPHERE LENS for daily wear…

Recall date

November 3, 2017

Source

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

Recall number

Z-0985-2018

FDA classification

Class II

Brand / firm

Alden Optical

Sold / distributed

Worldwide Distribution - US Nationwide in the states:of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, WY and the country of Canada.

Why it was recalled

Contact lenses lack sterility assurance.

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

What was recalled

Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.