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Recall Observatory FDA recall evidence

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.

Z-1821-2020

August 01, 2018

Class II

Product summary

Firm
Allied Vision Group Inc
Event
Event 84839
Status
Completed
Classification
Class II
Quantity
655 boxes with 6 units per box. total 3930
Official record key
device-enforcement:Z-1821-2020

Official wording

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

Code information: Lot numbers 31202568; 31255298; 31257909; 31229117; 31252252.

Distribution pattern: Worldwide and US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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