CLASS II Device recall · Reported 6 May 2020 · FDA Enforcement Report
Alcon Air Optix Night & Day Aqua (lotrafilcon A) recalled
Allied Vision Group is recalling Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 50 BC, distributed nationwide in the US. The recall was initiated on 1 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1821-2020
- FDA event ID
- 84839
- Recalling firm
- Allied Vision Group, Fort Lauderdale, FL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 1 Aug 2018
- FDA classified
- 29 Apr 2020
- Reported
- 6 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Contact Lenses & Eye Devices
Timeline
| 1 Aug 2018 | Recall initiated by company | |
| 29 Apr 2020 | Classified by FDA | +637 days |
| 6 May 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide and US Nationwide
Questions about this recall
Is Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 50 BC recalled?
Yes. Allied Vision Group recalled Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 50 BC on 1 Aug 2018. The recall is Class II and its status is Completed. Recall number Z-1821-2020.
Why was it recalled?
Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.
Which lots are affected?
Lot numbers 31202568; 31255298; 31257909; 31229117; 31252252.
Where was it sold?
Worldwide and US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Contact Lenses & Eye Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Tecnis Eyhance Iol with Tecnis Simplicity" Delivery System recalled | AMO Puerto Rico Manufacturing | Sterility | Nationwide |
| Device | CLASS II | Alcon PRECISION1 One-Day Contact Lenses, -2.25D recalled | Alcon Research | Sterility | 19 states |
| Device | CLASS II | Sofmed Breathables, (stenfilcon A) contact lens recalled by CooperVision | CooperVision | Mold | Nationwide |
| Device | CLASS II | Voyant 1-Day Premium Toric, (stenfilcon A) contact lens recalled | CooperVision | Mold | Nationwide |
| Device | CLASS II | MyDay Toric, stenfilcon A) Contact Lens recalled by CooperVision | CooperVision | Mold | Nationwide |