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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear see related information
Date Initiated by Firm January 06, 2017
Create Date March 03, 2017
Recall Status1 Open3, 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
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 2
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 and Original Applicant = THE SEE CLEAR COMPANY, INC
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