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Class 2 Device Recall Alcon Air Optix Night & Day Aqua |
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Date Initiated by Firm |
August 14, 2018 |
Create Date |
December 05, 2019 |
Recall Status1 |
Completed |
Recall Number |
Z-0609-2020 |
Recall Event ID |
83595 |
PMA Number |
P010019 |
Product Classification |
Lenses, soft contact, extended wear - Product Code LPM
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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. |
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. |
Recalling Firm/ Manufacturer |
Lens.com 4730 S Fort Apache Rd Ste 300 Las Vegas NV 89147-7947
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For Additional Information Contact |
Ms. Helen Junge 800-536-7266
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Manufacturer Reason for Recall |
The product may be counterfeit and could have microbial issues.
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FDA Determined Cause 2 |
Counterfeit |
Action |
The 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 Commerce |
1,600/6-contact lens cartons |
Distribution |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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PMA Database |
PMAs with Product Code = LPM and Original Applicant = Alcon Laboratories, Inc.
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