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U.S. Department of Health and Human Services

Class 2 Device Recall ASTERA

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  Class 2 Device Recall ASTERA 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-0991-2018
Recall Event ID 79377
510(K)Number K052703  
Product Classification Lenses, soft contact, daily wear - Product Code LPL
Product ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54

Product Usage:
The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/or possesses refractive astigmatism not exceeding 10 Diopters.
Code Information AZ128410 
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 4
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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