Z-0990-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- November 3, 2017
- Termination Date
- June 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 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/or possesses refractive astigmatism not exceeding 10 Diopters.
Reason for Recall
Contact lenses lack sterility assurance.
Distribution Pattern
Worldwide Distribution - US Nationwide 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, WY and the country of Canada.
Code Information
AZ162110 AZ162120 AZ158510 AZ158520 AZ160420