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Recall Observatory FDA recall evidence

Device 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 aphakic persons with otherwise non-diseased eyes and who possess refractive astigmatism not exceeding 10 Diopters.

Z-0982-2018

November 03, 2017

Class II

Product summary

Firm
Alden Optical
Event
Event 79377
Status
Terminated
Classification
Class II
Quantity
33
Official record key
device-enforcement:Z-0982-2018

Official wording

Reason: Contact lenses lack sterility assurance.

Code information: AZ150410 AZ125410 AZ143310 AZ143320 AZ119610 AZ139910 AZ139920 AZ119810 AZ119820 AZ147210 AZ147220 AZ155820 AZ155910 AZ155920 AZ152010 AZ152020 AZ144710 AZ144720 AZ153620 AZ150710 AZ121910 AZ121920

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Contact lenses lack sterility assurance.