Class 2 Device Recall Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear

• Date Initiated by Firm: January 06, 2017
• Create Date: March 03, 2017
• Recall Status: Open, Classified
• Recall Number: Z-1404-2017
• Recall Event ID: 76279
• 510(K)Number: K111345
• Product Classification: Lenses, soft contact, daily wear - Product Code LPL
• Product: Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
• Code Information: All lots of lenses sold between 10/31/2013 to 10/31/2016
• FEI Number: 3009384112
• Recalling Firm/ Manufacturer: The See Clear Company; 4995 Buford Hwy Ste 102; Peachtree Corners GA 30071-2721
• For Additional Information Contact: Kevin Randall; 303-828-0844
• Manufacturer Reason for Recall: Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
• FDA Determined Cause: Device Design
• Action: The firm, The See Clear Company, sent an "URGENT: DEVICE RECALL" letter dated 12/30/2016 to its Consignees on 01/06/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately examine your stock to determine if you have any of the listed product; immediately discontinue distributing the product and promptly return them via parcel post to Norcross facility, ATTENTION: RETURN GOODS; if you have further distributed any of the listed product, immediately contact your accounts, advise them of the recall, and have them return their outstanding recalled stocks to you; and immediately complete and return RECALL RETURN RESPONSE FORM via mail. If you have any questions, contact us at (678) 313-1399.
• Quantity in Commerce: 119,829 units
• Distribution: Worldwide Distribution: US (nationwide) including states of: AZ, CA, DE, FL, GA, HI, LA, NJ, NY, NV, ON, PA and WA; and 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LPL