Alden HP59 Toric Contact Lenses Recalled for Lack of Sterility Assurance
Alden Optical is recalling HP59 Toric Daily Wear Soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.
What this means for you
Illness, injury, or structural failure has been reported. 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, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in a medical device warrants a score of 4 (Severe), particularly given the potential for serious injury or hospitalization from non-sterile contact lenses.
Plain-English summary
Alden Optical is recalling Alden HP59 Toric Daily Wear Soft contact lenses (Catalog Number: AOHPT59) due to a lack of sterility assurance. The recall involves five units of the product.
The affected lenses 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 specific lot codes associated with this recall are AZ162110, AZ162120, AZ158510, AZ158520, and AZ160420.
Consumers who possess these contact lenses should stop using them immediately. The product is 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 recalled product
- Product
- Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 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 hyperopia) and/
- Manufacturer
- Alden Optical
- Category
- Medical Device — Contact Lenses
- Hazard
- Affected units
- 5
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)
- AZ162110 AZ162120 AZ158510 AZ158520 AZ160420
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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