Lens.com Recalls Alcon Air Optix Night & Day Aqua Contact Lenses
Lens.com is recalling specific lots of Alcon Air Optix Night & Day Aqua contact lenses because they may be counterfeit and have microbial issues.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of microbial issues in a medical device, which aligns with the 'Severe' criteria for significant injury risk or Class II recalls with potential for serious harm.
Plain-English summary
Lens.com is recalling 1,600 cartons of Alcon Air Optix Night & Day Aqua (lotrafilcon A) breathable contact lenses. The specific product configuration is 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 recall was initiated because the product may be counterfeit and could have microbial issues. The recall covers 21 specific lot numbers with expiration dates ranging from September 2020 to September 2021.
The recalling firm believes approximately 800 customers may have received potentially counterfeit product. Due to HIPAA regulations, the firm declined to provide a full consumer list with names, addresses, and emails, providing only a spreadsheet with first names, last initials, and zip codes. Consumers who purchased these specific lots should stop using the product and contact Lens.com for a refund or replacement.
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
- Lens.com
- 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 (20)
- Lot numbers 31248224
- exp. 2021/06
- 31251806
- exp. 2021/07
- 31252524
- 31202568
- exp. 2020/09
- 31247324
- 31255298
- exp. 2021/08
- 31231184
- exp. 2021/03
- 31257909
- 31247744
- 31240720
- exp. 2021/04
- 31252252
- 31251559
- exp.
- 2021/07
Distribution
Distribution scope not specified by the agency.
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