Alden Optical Recalls ASTERA Multifocal Toric Contact Lenses for Sterility Issues
Alden Optical is recalling ASTERA Multifocal Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects 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. According to the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. Lack of sterility assurance in contact lenses poses a significant risk of infection.
Plain-English summary
Alden Optical is recalling ASTERA Multifocal Toric Daily Wear Soft contact lenses (Catalog Number: AOAMT54) because the products lack sterility assurance. The recall is classified as Class II by the U.S. Food and Drug Administration.
The affected contact lenses are indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with refractive ametropia and/or refractive astigmatism not exceeding 10 Diopters. The recall covers 4 units with code AZ128410.
Distribution was worldwide, specifically including the US 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 Canada. Consumers should stop using the affected contact lenses and contact Alden Optical for further instructions.
The recalled product
- Product
- ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC 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
- 4
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)
- AZ128410
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.
See all 11 products in this recall →Related recalls
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