Events

Recall of DURASOFT FRESHLOOK COLORS CONTACT LENS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CIBA VISION CORPORATION.

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
    66138
  • Event Risk Class
    III
  • Event Initiated Date
    2004-03-15
  • 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
    Complaints received from customers stating poor vision compared to previous lenses of same type. it was determined that lens inside package does not match prescription info labeled on the primary package.

Device

DURASOFT FRESHLOOK COLORS CONTACT LENS
  • Model / Serial
    Model Catalog: FLUV (Lot serial: 65047); Model Catalog: FLUV (Lot serial: 74338); Model Catalog: FLUV (Lot serial: 73059)
  • Product Description
    FRESHLOOK SOFT CONTACT LENS
  • Manufacturer
    CIBA VISION CORPORATION

Manufacturer

CIBA VISION CORPORATION
  • Manufacturer Address
    DULUTH
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    HC