Events

Recall of Glaucoma Aqueous Shunt, 209 mm, valved

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Eagle Vision Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35214
  • Event Risk Class
    Class 2
  • Event Number
    Z-0845-06
  • Event Initiated Date
    2006-04-12
  • Event Date Posted
    2006-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45521
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implant, Eye Valve - Product Code KYF
  • Reason
    Product may have deformed valves which would cause the valve not to operate properly.
  • 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.

Device

Glaucoma Aqueous Shunt, 209 mm, valved
  • Model / Serial
    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.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Canada, Columbia, Turkey, & The Netherlands
  • Product Description
    Glaucoma Aqueous Shunt, 209 mm, valved, P/N EG209V
  • Manufacturer
    Eagle Vision Inc

Manufacturer

Eagle Vision Inc
  • Manufacturer Address
    Eagle Vision Inc, 8500 Wolf Lake Dr Ste 110, Memphis TN 38133-4104
  • Source
    USFDA