Recall Z-0846-06 ยท KYF Implant, Eye Valve
Eagle Vision Inc
Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V
| Date | May 6, 2006 (initiated Apr 12, 2006) |
| Status | Terminated |
| Reason | Product may have deformed valves which would cause the valve not to operate properly. |
| Root 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 | 22 units |
| Distribution | Nationwide, Canada, Columbia, Turkey, & The Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905703 | KRUPIN EYE VALVE WITH DISK Hood Laboratories, Mar 15, 1991 |