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U.S. Department of Health and Human Services

Class 2 Device Recall Alden HP49

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 Class 2 Device Recall Alden HP49see related information
Date Initiated by FirmNovember 03, 2017
Create DateMarch 13, 2018
Recall Status1 Terminated 3 on June 19, 2018
Recall NumberZ-0987-2018
Recall Event ID 79377
510(K)NumberK981252 
Product Classification Lenses, soft contact, daily wear - Product Code LPL
ProductAlden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49 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 AZ150010 AZ150020 AZ126720 AZ153710 AZ153720 AZ136110 AZ146910 AZ146920 AZ143710 AZ143720 AZ146610 AZ146620 AZ156210 AZ156220 AZ151510 AZ155210 AZ138410 AZ138420 AZ154810 AZ154620 AZ162310 AZ162320 AZ159810 AZ159820 AZ145220 AZ151120  
Recalling Firm/
Manufacturer		 Alden Optical
6 Lancaster Pkwy
Lancaster NY 14086-9713
For Additional Information ContactLeah Vilagy
716-458-1880
Manufacturer Reason
for Recall		Contact lenses lack sterility assurance.
FDA Determined
Cause 2		Process design
ActionConsignees 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 Commerce56
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = LPL
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