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Class 2 Device Recall Circle Lens, Europa, Pacifica, Gothika and Water Color. |
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Date Initiated by Firm |
May 10, 2006 |
Date Posted |
July 26, 2006 |
Recall Status1 |
Terminated 3 on July 25, 2012 |
Recall Number |
Z-1257-06 |
Recall Event ID |
35597 |
510(K)Number |
K051477
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Product Classification |
Soft Contact Lens - Product Code LPL
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Product |
Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water Color * Manufactured for Softlens Technology, Marietta, GA 30060. |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Hebron International, Inc. 5265 Buford Hwy. Atlanta GA 30340
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For Additional Information Contact |
John Patterson 678-797-1099
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Manufacturer Reason for Recall |
Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement.
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FDA Determined Cause 2 |
Other |
Action |
Consignees were notified by certified mail on 05/22/2006. |
Quantity in Commerce |
334,187 lenses |
Distribution |
Nationwide |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = LPL and Original Applicant = MI GWANG CONTACT LENS CO., LTD.
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