PlainRecalls
ModerateClass IICompleted

FDA Devices recall · Reported December 11, 2019

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.

The product may be counterfeit and could have microbial issues.

Recall #
Z-0609-2020
Affected scope
1,600/6-contact lens cartons
Initiated
August 14, 2018
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Lens.com recalled Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 B… - a moderate-severity action.

Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 B… was recalled by Lens.com in December 11, 2019. Reason: The product may be counterfeit and could have microbial issues.. Check the official notice for the remedy. Verify recall #Z-0609-2020 with the FDA Devices before acting.

The recall

Lens.com issued this moderate-severity FDA Devices recall-The product may be counterfeit and could have microbial issues..

Moderate
severity level
Class II
classification
December 11, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0609-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product 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 for recall

The product may be counterfeit and could have microbial issues.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Completed
Recall number Z-0609-2020
Date reported December 11, 2019
Date initiated August 14, 2018
Recalling firm Lens.com
Firm location Las Vegas, NV
Affected scope 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 ac…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-0609-2020) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Lens.com. Units affected: 1,600/6-contact lens cartons.
Why was this product recalled?
The product may be counterfeit and could have microbial issues.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 11, 2019. Severity: Moderate. Recall number: Z-0609-2020.
Where was the recalled product distributed?
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..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported December 11, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026