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U.S. Department of Health and Human Services

Class 2 Device Recall Alcon Air Optix Night & Day Aqua

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 Class 2 Device Recall Alcon Air Optix Night & Day Aquasee related information
Date Initiated by FirmAugust 14, 2018
Create DateDecember 05, 2019
Recall Status1 Completed
Recall NumberZ-0609-2020
Recall Event ID 83595
PMA NumberP010019 
Product Classification Lenses, soft contact, extended wear - Product Code LPM
ProductAlcon 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.
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.
FEI Number 3011073835
Recalling Firm/
Manufacturer		 Lens.com
4730 S Fort Apache Rd Ste 300
Las Vegas NV 89147-7947
For Additional Information ContactMs. Helen Junge
800-536-7266
Manufacturer Reason
for Recall		The product may be counterfeit and could have microbial issues.
FDA Determined
Cause 2		Counterfeit
ActionThe recalling firm sent undated emails beginning approximately 8/14/2018 to approximately 23,444 consumers and/or associated websites informing them the product they have received may be imitation.
Quantity in Commerce1,600/6-contact lens cartons
DistributionDue 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA DatabasePMAs with Product Code = LPM
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