Today, in a move widely supported by optometrists, ophthalmologists
and opticians, the Honourable Rona Ambrose, Minister of Health,
announced that Health Canada will be consulting on new guidance for
industry that will lead to non-corrective or ‘cosmetic’ contact lenses
being regulated as medical devices.
‘Cosmetic’ contact lenses (also called decorative lenses) are used to
change the colour or appearance of the eyes and are typically sold by
costume and cosmetic retailers. Until now, these types of lenses have
been regulated as consumer products. However the risks of decorative
lenses are identical to the risks of corrective lenses and adverse
events causing harm and even permanent damage to the eyes are not
uncommon.
As medical devices, cosmetic contact lenses would be subject to
specific requirements for licensing, manufacturing, labeling, and
instructions to improve their safety before they go on the market. The
proposed changes to the Medical Device Regulations
are being published in Canada Gazette I on October 18 to begin
consultations. In addition, new guidance documents and new application
forms will be posted on the Health Canada website for a 75-day comment
period.
Quick Facts
- Contact lenses are not suitable for everyone. Some people are more at risk of adverse reactions.
- Smokers who use contact lenses are eight times more likely to develop corneal ulcers than non-smokers, no matter which type of contact lenses they wear.
- According to a recent French study, the risk of severe corneal infection related to contact lens wear for cosmetic purposes is 12.5 times higher than with corrective contact lenses.
Quotes
“Improving patient safety is a priority for our Government. These new
measures will help to make cosmetic contact lenses safer for Canadians,
protecting our eyes and vision from needless harm.” Rona Ambrose Minister of Health
“I’m very pleased by the actions taken by the Government, in
accordance with Private Members Bill C-313, to ensure that moving
forward Cosmetic contact lenses are made subject to the same licensing,
manufacturing and labeling as has long been required for regular,
prescription contact lenses. I believe these consumer protection
measures announced today by the Government of Canada go a long way
towards addressing the concerns expressed by Canadian eye care
professionals from coast to coast to coast. “ Pat Davidson Member of Parliament: Sarnia-Lambton
“The Canadian Association of Optometrists and other vision
health professionals are concerned about the great risk of harm to the
eye and vision caused by the use of non-corrective contact lenses –
primarily due to improper use and supervision. We are very happy to see
these proposed new regulations moving forward.” Dr. Paul Geneau, President Canadian Association of Optometrists
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