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Class 2 Device Recall Glaucoma Aqueous Shunt, 209 mm, valved |
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Date Initiated by Firm |
April 12, 2006 |
Date Posted |
May 06, 2006 |
Recall Status1 |
Terminated 3 on September 13, 2006 |
Recall Number |
Z-0845-06 |
Recall Event ID |
35214 |
510(K)Number |
K905703
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Product Classification |
Implant, Eye Valve - Product Code KYF
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Product |
Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209V |
Code Information |
Serial numbers: 10727A, 10733A, 10734A, 10735A, 10736A, 10737A, 10744A, 10745A, 10746A, 10747A, 10748A, 10749A, 10750A, 10751A, 10794A, 107795A, 10796A, 10797A, 10798A, 10799A, 10806A, 11056A through 11101A, and 11443A through 11456A. |
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
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Manufacturer Reason for Recall |
Product may have deformed valves which would cause the valve not to operate properly.
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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 |
73 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 and Original Applicant = HOOD LABORATORIES
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