Z-1821-2020 Class II
FDA device recall Z-1821-2020 was initiated by Allied Vision Group Inc on August 1, 2018 and is designated Class II. Reason for recall: Potentially counterfeit products in/and counterfeit packaging were imported to the U.S. Affected quantity: 655 boxes with 6 units per box. total 3930.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2020
- Initiation Date
- August 1, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 655 boxes with 6 units per box. total 3930
Product Description
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.
Reason for Recall
Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.
Distribution Pattern
Worldwide and US Nationwide
Code Information
Lot numbers 31202568; 31255298; 31257909; 31229117; 31252252.