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 Air Optix Night & Day Aqua

  • 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 Air Optix Night & Day Aqua see related information
Date Initiated by Firm August 01, 2018
Create Date April 29, 2020
Recall Status1 Completed
Recall Number Z-1821-2020
Recall Event ID 84839
PMA Number P010019 
Product Classification Lenses, soft contact, extended wear - Product Code LPM
Product Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
Code Information Lot numbers 31202568; 31255298; 31257909; 31229117; 31252252.
Recalling Firm/
Manufacturer		 Allied Vision Group Inc
5350 Nw 35th Ave
Fort Lauderdale FL 33309-6314
For Additional Information Contact Robert Lesica
954-730-9244
Manufacturer Reason
for Recall		 Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.
FDA Determined
Cause 2		 Counterfeit
Action The firm initiated the recall by email on August 01, 2018 and followed with a second email on August 03, 2018. The email explained that the product was potentially non-genuine and offered a full refund or exchange of the product.
Quantity in Commerce 655 boxes with 6 units per box. total 3930
Distribution Worldwide and US Nationwide
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.
PMA Database PMAs with Product Code = LPM and Original Applicant = Alcon Laboratories, Inc.
-
-