Class 2 Device Recall Krupin Eye Valve

• Date Initiated by Firm: April 12, 2006
• Date Posted: May 06, 2006
• Recall Status: Terminated on September 13, 2006
• Recall Number: Z-0844-06
• Recall Event ID: 35214
• 510(K)Number: K905703
• Product Classification: Implant, Eye Valve - Product Code KYF
• Product: Krupin Eye Valve, P/N 6003
• Code Information: P/N 6003, Serial numbers: 10671A through 10714A; 10807A through 10813A; 108866A through 10905A
• Recalling Firm/ Manufacturer: Eagle Vision Inc; 8500 Wolf Lake Dr Ste 110; Memphis TN 38133-4104
• 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: 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: 94 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