| Class 2 Device Recall NovaKone | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LPL
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