Alden Classic 38 Sphere Daily Wear Soft Contact Lenses Recalled for Sterility Issues
Alden Optical is recalling Alden Classic 38 Sphere Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the United States 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a lack of sterility assurance in contact lenses, which poses a risk of harm (infection) even though specific injuries or illnesses are not reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alden Optical is recalling Alden Classic 38 Sphere Daily Wear Soft contact lenses, catalog number AOCLS38. The recall was initiated because the contact lenses lack sterility assurance. The product is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia.
The affected units were distributed worldwide, specifically in the United States (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, Wyoming) and Canada. The recall involves four units with lot codes AZ034720, AZ152310, and AZ152320.
Consumers who possess these contact lenses should stop using them immediately and contact Alden Optical for further instructions or a refund. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 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
- Hazard
- 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)
- AZ034720 AZ152310 AZ152320
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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