Alden HP49 Toric Contact Lenses Recalled for Sterility Assurance Issues
Alden Optical is recalling 56 units of Alden HP49 Toric Daily Wear Soft contact lenses because they lack sterility assurance. The lenses were distributed in 25 US states 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 is classified as FDA Class II. The hazard involves a lack of sterility assurance in contact lenses, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alden Optical is recalling 56 units of Alden HP49 Toric Daily Wear Soft contact lenses (Catalog Number: AOHPT49). The recall was initiated because the contact lenses lack sterility assurance. The product is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia and/or refractive astigmatism not exceeding 10 Diopters.
The affected units were distributed worldwide, specifically in the United States (California, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Wisconsin, Wyoming) and Canada. The recall number is Z-0987-2018.
Consumers who have these contact lenses should stop using them immediately and contact their eye care professional or Alden Optical for further instructions. The specific lot codes associated with this recall include AZ150010, AZ150020, AZ126720, AZ153710, AZ153720, AZ136110, AZ146910, AZ146920, AZ143710, AZ143720, AZ146610, AZ146620, AZ156210, AZ156220, AZ151510, AZ155210, AZ138410, AZ138420, AZ154810, AZ154620, AZ162310, AZ162320, AZ159810, AZ159820, AZ145220, and AZ151120.
The recalled product
- Product
- Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 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
- 56
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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