Events

Recall of Device Recall Volk G4 Small Ring, No Flange, Gonio Lens with case

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
    73213
  • Event Risk Class
    Class 3
  • Event Number
    Z-1177-2016
  • Event Initiated Date
    2016-02-02
  • Event Date Posted
    2016-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143579
  • 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
    Lens, contact, polymethylmethacrylate, diagnostic - Product Code HJK
  • Reason
    The firm discovered that the incorrect lot number was engraved on the product.
  • Action
    Volk Optical sent an Urgent Medical Device Recall letter dated February 4, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Also, if product was further distributed customers should identify their customers and notify them at once of the product recall and include a copy of the letter. The affected devices should be returned to Volk with an assigned Return Merchandise Authorization (RMA) number. Customers should contact Volk at (440) 942-6161 or toll free at (800) 345-8655 as soon as they receive the notification to setup a RMA for their device(s). Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with questions should call (440) 510-0745.

Device

Device Recall Volk G4 Small Ring, No Flange, Gonio Lens with case
  • Model / Serial
    Model #: VG4SNF, Lot: BE05200
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Virginia only) Internationally to Canada, France & Indonesia.
  • Product Description
    Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 || for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities
  • 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