Recall Z-1821-2020 ยท LPM Lenses, Soft Contact, Extended Wear
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.
| Date | Aug 1, 2018 |
| Status | Completed |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.