FDA recall Z-1821-2020

Allied Vision Group Inc · Class II · device

Product

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.

Reason for recall

Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.

Distribution

Worldwide and US Nationwide

Key facts

Status
Completed
Initiation date
2018-08-01
Report date
2020-05-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fort Lauderdale, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1821-2020