2011-156
November 16, 2011
For immediate release

OTTAWA – CooperVision, in consultation with Health Canada, is expanding the  product list of their voluntary worldwide recall of contact lenses. Health Canada is working with the company to identify which products on the Canadian market are affected by the recall. This recall is due to the presence of a residue (silicone oil) on the lenses with certain lots of products. According to the company, the presence of the residue may cause hazy vision or discomfort, severe eye pain or eye injuries requiring medical treatment.

Health Canada recommends that consumers should consult with their healthcare practitioner with any questions or concerns regarding the use of these contact lenses. CooperVision is recommending that consumers stop wearing the affected lenses immediately and contact their eye care practitioner for advice.

Health Canada has been advised by CooperVision that they have taken corrective action to fix the problem associated with the use of their products. Consumers and retailers should contact the company directly at 1-855-526-6737 for more information.

Canadians can be confident that Health Canada is monitoring the voluntary recall by CooperVision. Should additional information be identified, Health Canada will take appropriate action and inform Canadians.

To report suspected adverse events to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: 1-866-678-6789
• Internet: www.healthcanada.gc.ca/medeffect
• Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701E
  K1A 0K9

Complaints involving medical devices can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:

Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9

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