Z-0982-2018 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
- 33
Product Description
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 aphakic persons with otherwise non-diseased eyes and who possess 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
AZ150410 AZ125410 AZ143310 AZ143320 AZ119610 AZ139910 AZ139920 AZ119810 AZ119820 AZ147210 AZ147220 AZ155820 AZ155910 AZ155920 AZ152010 AZ152020 AZ144710 AZ144720 AZ153620 AZ150710 AZ121910 AZ121920