Events

Recall of Device Recall Standard Gonio Lens

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Volk Optical 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
    52453
  • Event Risk Class
    Class 3
  • Event Number
    Z-1710-2009
  • Event Initiated Date
    2008-06-30
  • Event Date Posted
    2009-07-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83075
  • 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
    Prism, gonioscopic - Product Code HKS
  • Reason
    The ring of the gonio lenses distributed was engraved as, 'g4 high mag gonio lnf'; however, the engraving should have read simply: 'g4 high mag gonio.'.
  • Action
    Volk Optical Inc. contacted their customers and notified them of affected device via E-mail, letter, and Fax transmittals starting June 30, 2008. The recall notification(s) describes the engraving error and instructs the users on steps to replace the affected product. For further questions, contact Volk Optical Inc. at 1-800-345-8655 extension 443 .

Device

Device Recall Standard Gonio Lens
  • Model / Serial
    The device was identified with the Lot Code: A1050030.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Great Britain, China and the U.S.
  • Product Description
    G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.
  • Manufacturer
    Volk Optical Inc

Manufacturer

Volk Optical Inc
  • Manufacturer Address
    Volk Optical Inc, 7893 Enterprise Dr, Mentor OH 44060-5309
  • Manufacturer Parent Company (2017)
    Halma Plc
  • Source
    USFDA