Events

Recall of G-4 GONIO NF LENS

According to Health Canada (via FOI), this recall involved a device in Canada 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
    142903
  • Event Risk Class
    III
  • Event Initiated Date
    2016-03-31
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    This recall has been initiated due to mislabeling. the device's packaging was labeled with a different lot number than the lot number that was engraved on the ring of the device. the lens was sent in with lot#bd05200 engraved but it should've been be05200.

Device

G-4 GONIO NF LENS
  • Model / Serial
    Model Catalog: VG4SNF (Lot serial: BEOS200)
  • Product Description
    VOLK G-4 SMAll RING NO FLANGE GONIO LENS WITH CASE
  • Manufacturer
    VOLK OPTICAL INC.

Manufacturer

VOLK OPTICAL INC.
  • Manufacturer Address
    MENTOR
  • Manufacturer Parent Company (2017)
    Halma Plc
  • Source
    HC