Medical device recalls Moderate risk

Johnson & Johnson Vision Care, Inc. recalls Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 s…

Recall date
July 23, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2916-2018
FDA classification
Class II
Brand / firm
Johnson & Johnson Vision Care, Inc.
Sold / distributed
Worldwide distribution: US (Nationwide) distribution to CA, CT, FL, GA, IA, IL, MA, MD, ME, MO, NC, NE, NH, NJ, NY, OH, PA, TN, TX, UT, and VA, Puerto Rico; and countries of: Canada, Barbados, Japan, and Korea.

Why it was recalled

Johnson and Johnson Vision Care received a number of reports of a partially formed contact lens, which appears to the customer or consumer as visibly smaller in diameter, thicker/stiffer to the touch and more darkly tinted blue than the normal contact lens.

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

What was recalled

Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 split lots, repackaged in 30 and 90-packs . Intended for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

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