Alden Optical Recalls NovaKone Toric Contact Lenses for Sterility Issues
Alden Optical is recalling 33 units of NovaKone Toric Daily Wear Soft contact lenses because they lack sterility assurance. The lenses were distributed in 25 US 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 involves a risk-of-harm product (lack of sterility assurance) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Alden Optical is recalling 33 units of NovaKone Toric Daily Wear Soft contact lenses (Catalog Number AONKT54). The recall was initiated because the contact lenses lack sterility assurance. The product is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia in aphakic and not aphakic persons.
The affected units were distributed worldwide, specifically 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 the country of Canada. The recall includes specific lot codes such as AZ150410, AZ125410, and AZ143310.
Consumers who possess these contact lenses should stop using them immediately and contact Alden Optical for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not…
- Manufacturer
- Alden Optical
- Category
- Medical Device — Contact Lenses
- Affected units
- 33
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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