Alden Classic 55 Toric Contact Lenses Recalled for Sterility Issues
Alden Optical is recalling Alden Classic 55 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.
What this means for you
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 lack of sterility assurance, which poses a risk of harm (infection) even though no specific injuries or illnesses are 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 55 Toric Daily Wear Soft contact lenses (Catalog Number: AOCLT55) due to a lack of sterility assurance. The product is indicated for the correction of visual acuity in individuals with refractive ametropia and/or astigmatism not exceeding 10 Diopters.
The recall covers units distributed worldwide, specifically in the United States (including states such as 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) and Canada. The specific code information associated with the recall is AZ133020.
Consumers should stop using the affected contact lenses immediately and contact their eye care professional or Alden Optical for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Alden Classic 55 Toric Daily Wear Soft contact; Catalog Number: AOCLT55 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
- Affected units
- 1
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)
- AZ133020
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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