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U.S. Department of Health and Human Services

Class 2 Device Recall NovaKone

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  Class 2 Device Recall NovaKone see related information
Date Initiated by Firm November 03, 2017
Create Date March 13, 2018
Recall Status1 Terminated 3 on June 19, 2018
Recall Number Z-0982-2018
Recall Event ID 79377
510(K)Number K102557  
Product Classification Lenses, soft contact, daily wear - Product Code LPL
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.
Code Information AZ150410 AZ125410 AZ143310 AZ143320 AZ119610 AZ139910 AZ139920 AZ119810 AZ119820 AZ147210 AZ147220 AZ155820 AZ155910 AZ155920 AZ152010 AZ152020 AZ144710 AZ144720 AZ153620 AZ150710 AZ121910 AZ121920 
Recalling Firm/
Manufacturer		 Alden Optical
6 Lancaster Pkwy
Lancaster NY 14086-9713
For Additional Information Contact Leah Vilagy
716-458-1880
Manufacturer Reason
for Recall		 Contact lenses lack sterility assurance.
FDA Determined
Cause 2		 Process design
Action Consignees were initially called and told over the phone not to further distribute the contact lenses. For two consignees whose patients could not be reached by phone, a letter was sent. The consignee letter states the specific product and lot should not be further distributed due to the lack of sterility assurance. A business reply card was provided with the letter and contacts should be returned to the manufacturer using a label provided by the firm.
Quantity in Commerce 33
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPL and Original Applicant = ALDEN OPTICAL LABS., INC.
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