Events

Recall of ENFILCON DK100 ASPHERIC

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
    24481
  • Event Risk Class
    I
  • Event Initiated Date
    2013-10-29
  • 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
    Certain lots of the affected lenses did not meet the new manufacturing acceptance limit for the presence of residue (silicone oil) which may cause hazy vision or discomfort severe eye pain or eye injuries requiring medical treatment.

Device

ENFILCON DK100 ASPHERIC
  • Model / Serial
    Model Catalog: ENFILCON DK100 ASPHERIC (Lot serial: ); Model Catalog: ENFILCON A SOFT CONTACT LENS (Lot serial: >100 NUMBERS CONTACT MFG); Model Catalog: ENFILCON A SOFT CONTACT LENS (Lot serial: FOR ALL); Model Catalog: 2 CLEAR COMFORT (Lot serial: ); Model Catalog: ENCORE100 SPHERE (Lot serial: ); Model Catalog: MEDIFLEX AQUAFINITY 125 (Lot serial: )
  • Product Description
    ENFILCON DK100 ASPHERIC
  • Manufacturer
    COOPERVISION CANADA CORP.

Manufacturer

COOPERVISION CANADA CORP.