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Class 2 Device Recall Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear |
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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
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Product Classification |
Lenses, soft contact, daily wear - Product Code LPL
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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
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For Additional Information Contact |
Kevin Randall 303-828-0844
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Manufacturer Reason for Recall |
Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot numbers and expiry dates.
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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
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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.
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510(K) Database |
510(K)s with Product Code = LPL and Original Applicant = THE SEE CLEAR COMPANY, INC
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