Z-0609-2020Class II

Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx...

Name: Z-0609-2020 Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx...
Creator: Lens.com
Published: 2018-08-14
License: https://open.fda.gov/license/

Lens.com, Inc. / initiated 2018-08-14 / Completed

FDA source

Lens.com began a recall of 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... on 2018-08-14. FDA classified it as Class II and gives the reason as "The product may be counterfeit and could have microbial issues". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0609-2020
Classification: Class II
Status: Completed
Initiated: 2018-08-14
Posted: 2019-12-05
Recalling firm: Lens.com, Inc.
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.
Product code: LPM Lenses, Soft Contact, Extended Wear
Reason for recall: The product may be counterfeit and could have microbial issues.
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0609-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0609-2020	Class II	Completed	Voluntary: Firm initiated	2019-12-11	2019-12-05

Product code LPM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)