Alden Optical Recalls HP49 Sphere Daily Wear Soft Contact Lenses
Alden Optical is recalling 23 units of HP49 Sphere Daily Wear Soft contact lenses because they lack sterility assurance.
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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). Lack of sterility assurance in contact lenses poses a significant risk of eye infection.
Plain-English summary
Alden Optical is recalling 23 units of Alden HP49 Sphere Daily Wear Soft contact lenses (Catalog Number: AOHPS49). The recall is being conducted because the contact lenses lack sterility assurance.
The affected products were distributed worldwide, including 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. The recall involves specific lot codes: AZ150110, AZ150120, AZ103810, AZ053210, AZ150510, AZ117720, AZ134110, AZ151520, AZ071720, AZ130410, and AZ130420.
Consumers who possess these specific contact lenses should stop using them immediately and contact Alden Optical for further instructions.
The recalled product
- Product
- Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 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…
- Manufacturer
- Alden Optical
- Category
- Medical Device — Contact Lenses
- Affected units
- 23
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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