Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Alden HP49

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Alden HP49 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-0987-2018
Recall Event ID 79377
510(K)Number K981252  
Product Classification Lenses, soft contact, daily wear - Product Code LPL
Product Alden 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 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 56
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.
-
-