# FDA recall Z-0609-2020

> **Lens.com** · Class II · device recall initiated 2018-08-14.

## Product

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 for recall

The product may be counterfeit and could have microbial issues.

## 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.

## Key facts

- **Recall number:** Z-0609-2020
- **Recalling firm:** Lens.com
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2018-08-14
- **Report date:** 2019-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Las Vegas, NV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0609-2020

## Citation

> AI Analytics. FDA recall Z-0609-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0609-2020. Source: US FDA. Licensed CC0.

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