| Class 2 Device Recall Circle Lens, Europa, Pacifica, Gothika and Water Color. | |
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 |
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 |
Manufacturer Reason for Recall | Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement. |
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
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