Medical device recalls Moderate risk

Alden Optical recalls Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC LENS for daily wear is…

Recall date
November 3, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0990-2018
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 HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC 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) and/or possesses refractive astigmatism not exceeding 10 Diopters.

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