Alcon Air Optix Night & Day Aqua Contact Lenses Recalled for Counterfeit Concerns
Allied Vision Group is recalling specific lots of Alcon Air Optix Night & Day Aqua contact lenses because potentially counterfeit products and packaging were imported to the U.S.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves potentially counterfeit medical devices, which poses a risk of harm due to unknown composition or quality, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Allied Vision Group Inc is recalling specific lots of Alcon Air Optix Night & Day Aqua (lotrafilcon A) breathable contact lenses. The recall involves 655 boxes, containing a total of 3,930 units, distributed worldwide and nationwide in the U.S. The affected lot numbers are 31202568, 31255298, 31257909, 31229117, and 31252252.
The recall was initiated because potentially counterfeit products and counterfeit packaging were imported to the United States. The agency classification for this recall is Class II.
Consumers who have these specific lot numbers should stop using the contact lenses and contact their eye care professional or the recalling firm for further instructions.
The recalled product
- 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.
- Manufacturer
- Allied Vision Group Inc
- Category
- Medical Device — Contact Lenses
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot numbers 31202568
- 31255298
- 31257909
- 31229117
- 31252252.
Distribution
Distributed nationwide across the United States.
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