Recall Z-0609-2020 ยท LPM Lenses, Soft Contact, Extended Wear
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.
| Date | Aug 14, 2018 |
| Status | Completed |
| 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 beli |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.