Class 2 Device Recall Air Optix Night & Day Aqua

• Date Initiated by Firm: August 01, 2018
• Create Date: April 29, 2020
• Recall Status: 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: 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