Z-0846-06

Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V

Name: Z-0846-06 Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V
Creator: Eagle Vision Inc
Published: 2006-04-12
License: https://open.fda.gov/license/

Grace Medical, Inc. / initiated 2006-04-12 / Terminated

FDA source

Eagle Vision Inc began a recall of Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V on 2006-04-12. The reason FDA records is "Product may have deformed valves which would cause the valve not to operate properly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0846-06
Status: Terminated
Initiated: 2006-04-12
Posted: 2006-05-06
Terminated: 2006-09-13
Recalling firm: Grace Medical, Inc.
Product: Glaucoma Aqueous Shunt 365 mm, valved, P/N EG365V
Product code: KYF Implant, Eye Valve
Reason for recall: Product may have deformed valves which would cause the valve not to operate properly.
FDA 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 in commerce: 22 units
Distribution: Nationwide, Canada, Columbia, Turkey, & The Netherlands
Product codes and lots: Serial numbers: 10744A through 10751A, 11042A through 11047A, 11511A, 11512A, 11518A, 11550A, 11551A, 11554A, 11556A, and 11559A

Product code KYF

K905703Class IIKrupin Eye Valve with DiskHood Laboratories / cleared 1991-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)