Alden Optical recalls ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC LENS for daily…
- Recall date
- November 3, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0991-2018
- 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
ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 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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