FDA Medical Device Recalls (openFDA)
Lens.com: 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.
- Recall number
- Z-0609-2020
- Recalling firm
- Lens.com
- 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.
- Status
- Completed
- Initiated
- 2018-08-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- The product may be counterfeit and could have microbial issues.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P010019"]
- Product code
- LPM
- Firm FEI
- 3011073835
- Firm city
- Las Vegas
- Firm state
- NV
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28