Class 2 Device Recall AVAIRA Soft Contact Lenses

• Date Initiated by Firm: November 09, 2012
• Date Posted: January 03, 2013
• Recall Status: Terminated on May 09, 2014
• Recall Number: Z-0631-2013
• Recall Event ID: 63719
• 510(K)Number: K113759
• Product Classification: Lenses, soft contact, daily wear - Product Code LPL
• Product: AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
• Code Information: 10447500016006, 10519550007006, 10537500016014
• Recalling Firm/ Manufacturer: Cooper Vision Caribbean Corp.; #500 Road 584; Amuelas Industrial Park; Juana Diaz PR 00795
• Manufacturer Reason for Recall: The lenses exceeded the acceptance limit for silicone oil residual.
• FDA Determined Cause: Material/Component Contamination
• Action: The recall was conducted to the wholesale/distributor and Eye Care Practitioner level. The company contacted the Authorized Distributors by telephone, followed by written notification dated November 9, 2012. All written notifications to first consignees, for both revenue and Fit Sets, were sent by overnight mail with signature required as proof of receipt and the envelopes were marked "Urgent". The notifications described the issue and provided recommended actions. Customers may contact 800-341-2020 if questions.
• Quantity in Commerce: 246
• Distribution: US Nationwide, including Puerto Rico, and 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 = COOPERVISION, INC.