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-0609-2020 · Initiated August 14, 2018

Recall

Recall Number
Z-0609-2020
Event Number
83595
Firm
Lens.com
FEI Number
3011073835
Product Code
LPM
Status
Completed
Root Cause
Counterfeit
Initiated
August 14, 2018
Address
4730 S Fort Apache Rd, Ste 300, Las Vegas, NV, 89147-7947

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

The product may be counterfeit and could have microbial issues.

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.

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 believes approximately 800 of them to have received potentially counterfeit product. The recalling firm was requested to provide a consumer spreadsheet showing the name, shipping address, and email address but declined because they thought it would be a violation of HIPAA regulations.

Quantity

1,600/6-contact lens cartons