FDA Recall
Completed
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: Z-1821-2020
·
Initiated August 1, 2018
Recall
- Recall Number
- Z-1821-2020
- Event Number
- 84839
- Firm
- Allied Vision Group Inc
- FEI Number
- 1000122287
- Product Code
- LPM
- Status
- Completed
- Root Cause
- Counterfeit
- Initiated
- August 1, 2018
- Address
- 5350 Nw 35th Ave, Fort Lauderdale, FL, 33309-6314
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
Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.
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.
Distribution
Worldwide and US Nationwide
Quantity
655 boxes with 6 units per box. total 3930