Alden Optical Recalls Zen RC Toric Contact Lenses with Incorrect Contents
Alden Optical is recalling Zen RC Toric contact lenses because vials labeled for specific prescriptions contained incorrect lenses.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a labeling/contents mismatch rather than a direct physical defect or contamination.
Plain-English summary
Alden Optical is recalling Zen RC Toric-Gas permeable contact lenses for Daily Wear. The recall involves 4 vials of the product, which are indicated for the correction of refractive ametropia in aphakic and nonaphakic persons with non-diseased eyes.
The reason for the recall is that vials labeled for the prescriptions contained incorrect lenses. This discrepancy means the lenses inside the vials may not match the specific prescription parameters required for the patient's vision correction.
The affected products were distributed in the United States in the states of California, Georgia, Illinois, Maryland, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and Utah. Consumers who have these specific vials should stop using them and contact their eye care professional or Alden Optical for instructions on how to proceed.
The recalled product
- Product
- Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the…
- Manufacturer
- Alden Optical
- Category
- Medical Device — Contact Lenses
- Affected units
- 4
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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