| Class 2 Device Recall Glaucoma Aqueous Shunt 365 mm, valved |  |
Date Initiated by Firm | April 12, 2006 |
Date Posted | May 06, 2006 |
Recall Status1 |
Terminated 3 on September 13, 2006 |
Recall Number | Z-0846-06 |
Recall Event ID |
35214 |
510(K)Number | K905703 |
Product Classification |
Implant, Eye Valve - Product Code KYF
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Product | Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V |
Code Information |
Serial numbers: 10744A through 10751A, 11042A through 11047A, 11511A, 11512A, 11518A, 11550A, 11551A, 11554A, 11556A, and 11559A |
Recalling Firm/ Manufacturer |
Eagle Vision Inc 8500 Wolf Lake Dr Ste 110 Memphis TN 38133-4104
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For Additional Information Contact | Wade Allen 901-380-7000 |
Manufacturer Reason for Recall | Product may have deformed valves which would cause the valve not to operate properly. |
FDA Determined Cause 2 | Other |
Action | Written notification of the recall was sent out beginning 04/12/2006 to hospital administrators to advise them of the recall. The letter stated that implanting physicians were to be notified. A second updated notice was sent dated 04/19/2006 which contained more detailed information regarding the product problem. |
Quantity in Commerce | 22 units |
Distribution | Nationwide, Canada, Columbia, Turkey, & The Netherlands |
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 = KYF
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