Alden HP54 Toric Contact Lenses Recalled for Sterility Assurance Issues
Alden Optical is recalling HP54 Toric 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 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 involves a medical device with a risk of harm (lack of sterility assurance) where no specific injuries or illnesses have been reported in the source text, aligning with the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Alden Optical is recalling Alden HP54 Toric Daily Wear Soft contact lenses (Catalog Number: AOHPT54) due to a lack of sterility assurance. The recall covers 14 units distributed worldwide, including nationwide in the United States and in Canada.
The affected product is indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. The specific lot codes associated with this recall are AZ150620, AZ159220, AZ156710, and AZ156720.
Consumers who possess these contact lenses should stop using them immediately. The source text does not specify a return address or further instructions for disposal or exchange.
The recalled product
- Product
- Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54 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)…
- Manufacturer
- Alden Optical
- Category
- Medical Device — Contact Lenses
- Hazard
- Affected units
- 14
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)
- AZ150620 AZ159220 AZ156710 AZ156720
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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