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U.S. Department of Health and Human Services

Class 2 Device Recall Glaucoma Aqueous Shunt 365 mm, valved

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  Class 2 Device Recall Glaucoma Aqueous Shunt 365 mm, valved see related information
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
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/
Eagle Vision Inc
8500 Wolf Lake Dr Ste 110
Memphis TN 38133-4104
For Additional Information Contact Wade Allen
Manufacturer Reason
for Recall
Product may have deformed valves which would cause the valve not to operate properly.
FDA Determined
Cause 2
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

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.
510(K) Database 510(K)s with Product Code = KYF and Original Applicant = HOOD LABORATORIES