FDA Medical Device Recalls (openFDA)
Allied Vision Group Inc: 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-1821-2020
- 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.
- Status
- Completed
- Initiated
- 2018-08-01
- Posted
- not on file
- Terminated
- not on file
- Reason
- Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.
- 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
- 655 boxes with 6 units per box. total 3930
- Distribution
- Worldwide and US Nationwide
- Lot, serial or model codes
- Lot numbers 31202568; 31255298; 31257909; 31229117; 31252252.
- 510(k) numbers
- not on file
- PMA numbers
- ["P010019"]
- Product code
- LPM
- Firm FEI
- 1000122287
- Firm city
- Fort Lauderdale
- Firm state
- FL
- 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