FDA-Device2019-12-11Class II
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.
Lens.com
Hazard
The product may be counterfeit and could have microbial issues.
Sold states
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 believes approximately 800 of them to have received potentially counterfeit product. The recalling firm was requested to provide a consumer spreadsheet showing the name, shipping address, and email address but declined because they thought it would be a violation of HIPAA regulations.
Affected count
1,600/6-contact lens cartons
Manufactured in
4730 S Fort Apache Rd Ste 300, Las Vegas, NV, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0609-2020Don't want to check this manually?
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