Z-1821-2020Class II

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

Name: Z-1821-2020 Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx...
Creator: Allied Vision Group Inc
Published: 2018-08-01
License: https://open.fda.gov/license/

Allied Vision Group Inc / initiated 2018-08-01 / Completed / root cause: packaging

FDA source

Allied Vision Group Inc 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 2018-08-01. FDA classified it as Class II and gives the reason as "Potentially counterfeit products in/and counterfeit packaging were imported to the U.S". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1821-2020
Classification: Class II
Status: Completed
Initiated: 2018-08-01
Posted: 2020-04-29
Recalling firm: Allied Vision Group 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: Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.
Root cause tag: packaging
FDA root cause: Counterfeit
Action: The firm initiated the recall by email on August 01, 2018 and followed with a second email on August 03, 2018. The email explained that the product was potentially non-genuine and offered a full refund or exchange of the product.
Quantity in commerce: 655 boxes with 6 units per box. total 3930
Distribution: Worldwide and US Nationwide
Product codes and lots: Lot numbers 31202568; 31255298; 31257909; 31229117; 31252252.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1821-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1821-2020	Class II	Completed	Voluntary: Firm initiated	2020-05-06	2020-04-29

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)