Events

Recall of ENFILCON A SOFT CONTACT LENS - ENCORE100 TORIC

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOPERVISION CANADA CORP..

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
    30872
  • Event Risk Class
    II
  • Event Initiated Date
    2011-08-29
  • 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
    There is unintended presence of a residue on lenses from certain lots of encore100 toric contact lenses. the company received complaints of temporary hazy or blurry vision and discomfort most likely caused by transient or reversible swelling of the surface layer of the cornea which is known as corneal epithelial edema.

Device

ENFILCON A SOFT CONTACT LENS - ENCORE100 TORIC
  • Model / Serial
    Model Catalog: (Lot serial: >1000 (CONTACT MANUFACTURER))
  • Product Description
    ENCORE100 TORIC SOFT CONTACT LENS
  • Manufacturer
    COOPERVISION CANADA CORP.

Manufacturer

COOPERVISION CANADA CORP.