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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.

FDA Recall Z-0609-2020 · Posted None

Recalling FirmLens.com
Recall StatusCompleted
Product CodeLPM
Date Initiated2018-08-14
Product Quantity1,600/6-contact lens cartons

Reason for Recall

The product may be counterfeit and could have microbial issues.

Firm 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.

Root Cause

Counterfeit

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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