Alden Optical Recalls NovaKone Daily Wear Soft Contact Lenses
Alden Optical is recalling NovaKone Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the US and Canada.
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. The hazard involves a lack of sterility assurance for a medical device, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Alden Optical is recalling specific units of NovaKone Daily Wear Soft contact lenses, catalog number AONKS54. The recall is due to a lack of sterility assurance for the product.
The affected lenses were distributed worldwide, including nationwide in the United States and in Canada. The specific distribution states in the US include California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin, and Wyoming. The recall involves three units with lot codes AZ154920 and AZ154720.
Consumers who possess these contact lenses should stop using them immediately and contact Alden Optical for further instructions.
The recalled product
- Product
- NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons…
- Manufacturer
- Alden Optical
- Category
- Medical Device — Contact Lenses
- Affected units
- 3
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 (1)
- AZ154920 AZ154720
Distribution
Part of a larger recall action
This product is one of 11 recalled by Alden Optical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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