Class 2 Device Recall 24k Premium contact lenses

• Date Initiated by Firm: March 20, 2024
• Date Posted: July 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2270-2024
• Recall Event ID: 94692
• Product Classification: Lens, contact, (disposable) - Product Code MVN
• Product: 24K Premium Lense, Distributed by Updream Inc.
• Code Information: All distributed lenses.
• FEI Number: 3030098668
• Recalling Firm/ Manufacturer: Ontact Inc; 10944 Playa Del Sol; Riverside CA 92503-5243
• Manufacturer Reason for Recall: Contact lenses recalled due to potential bacterial contamination.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 3/20/24, the firm started visiting consignees, verbally notifying them of the recall, and collecting remaining product.
• Quantity in Commerce: 2,842
• Distribution: US Nationwide distribution in the states of California and Nevada.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.