Alden Optical Recalls Contact Lenses Lacking Sterility Assurance
Alden Optical is recalling specific daily wear soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.
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 in a medical device, which poses a significant risk of serious injury or adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Alden Optical is recalling Alden HP54 Sphere Daily Wear Soft contact lenses (Catalog Number: AOHPS54) because the products lack sterility assurance. The recall covers two units of the product.
The affected lenses are indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be worn by persons with refractive astigmatism of 1.50 diopters or less. The products were distributed nationwide in the United States in the states of CA, FL, GA, ID, IL, IN, KS, KY, MD, MI, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, TX, VA, WI, and WY, as well as in Canada.
Consumers should stop using the affected contact lenses immediately. The specific lot codes associated with this recall are AZ160210 and AZ151320.
The recalled product
- Product
- Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia).…
- Manufacturer
- Alden Optical
- Category
- Medical Device — Contact Lenses
- Hazard
- Affected units
- 2
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)
- AZ160210 AZ151320
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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