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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-0981-2018
Recall Event ID 79377
510(K)Number K102557  
Product Classification Lenses, soft contact, daily wear - Product Code LPL
Product NovaKone Daily Wear Soft contact; Catalog Number: AONKS54

Product Usage:
The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with otherwise nondiseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

Code Information AZ154920 AZ154720 
Recalling Firm/
Alden Optical
6 Lancaster Pkwy
Lancaster NY 14086-9713
For Additional Information Contact Leah Vilagy
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 3
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.