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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-0609-2020

August 14, 2018

Class II

Product summary

Firm
Lens.com
Event
Event 83595
Status
Completed
Classification
Class II
Quantity
1,600/6-contact lens cartons
Official record key
device-enforcement:Z-0609-2020

Official wording

Reason: The product may be counterfeit and could have microbial issues.

Code information: Lot numbers 31248224, exp. 2021/06; 31251806, exp. 2021/07; 31252524, exp. 2021/07; 31202568, exp. 2020/09; 31247324, exp. 2021/06; 31255298, exp. 2021/08; 31231184, exp. 2021/03; 31257909, exp. 2021/08; 31247744, exp. 2021/06; 31240720, exp. 2021/04; 31252252, exp. 2021/07; 31251559, exp., 2021/07; 31243321, exp. 2021/05; 31259174, 2021/09; 31256939, exp. 2021/08; 31257917, exp. 2021/08; 31256939, exp. 2021/08; 31257917, exp. 2021/08; 31242179, exp. 2021/05; 31251806, exp. 2021/07; and 31252524, exp. 2021/07.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The product may be counterfeit and could have microbial issues.