Alden Optical recalls NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for…

Recall date

November 3, 2017

Source

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

Recall number

Z-0982-2018

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

NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with otherwise non-diseased eyes and who possess refractive astigmatism not exceeding 10 Diopters.