Medical device recalls Moderate risk

Lens.com recalls Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. T…

Recall date
August 14, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0609-2020
FDA classification
Class II
Brand / firm
Lens.com
Sold / distributed
Due to HIPAA, the firm only provided a spreadsheet that contained the first name, last initial, and zip code of each customer who received email notification of the recall. Out of the 23,444 unique names on this list (25,162 names were actually listed due to multiple consumer orders), the firm beli…

Why it was recalled

The product may be counterfeit and could have microbial issues.

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

What was recalled

Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

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