2018-2019 Compliance Monitoring Project (CMP) on Decorative Contact Lenses

Decorative contact lenses (DCLs), also called non-corrective or cosmetic lenses, are used to change the color or appearance of the eyes and are sold at costume and cosmetic retailers, primarily before Halloween. DCLs were reclassified as Class II medical devices in July 2016 due to their potential health risks. To be sold in Canada, DCLs must have a Medical Device Licence and be labelled according to the Medical Devices Regulations (MDR).

In order to increase industry awareness of the applicability of the MDR to DCLs, Health Canada conducted compliance promotion activities throughout 2017, including the issuance of educational letters and a Notice on Decorative Contact Lenses to manufacturers and optometrist and optician associations.

What are the risks of using unlicensed decorative contact lenses?

It is important for medical devices to be properly licensed and labelled to ensure they meet all health and safety requirements under the MDR. Unlicensed medical devices have not been assessed by Health Canada for safety, efficacy or quality and may pose a risk to the health and safety of Canadian consumers.

Contact lenses, including DCLs, may pose risks to consumers, including:

• cuts or scratches on the eye (corneal abrasions)
• allergic reactions (e.g., itchy, watery, red eyes)
• vision impairment
• infections
• blindness

What did we do?

Throughout October and November 2018, Health Canada inspectors visited and reviewed twenty-three randomly selected physical retail outlets and thirty-nine internet retail sites advertising the sale of DCLs in Canada. Physically visited sites included optical, gift and cosmetic, pop-up Halloween, theatrical/costume, and health and beauty retailers. Health Canada inspectors examined numerous decorative contact lenses for appropriate licenses and labels.

What did we find?

Of the non-compliant products identified by this project, most involved a lack of device licence. However, a number of labelling deficiencies were noted, even among licensed devices. Those deficiencies included an absence of medical device identifier and poor or inadequate instructions for use.

Inspectors determined that 35% (8 of 23) of randomly selected retail outlets and 59% (23 of 39) of internet retailers failed to comply with medical device licensing and labelling requirements.

Five hundred and eighty four units (pairs) of diverted, or grey market DCLs were found at retail outlets in British Columbia. Diverted products are sold in a market for which they were not manufactured and may not be stored, handled or distributed properly, may not be safe or effective, and instructions for use may not be in the official languages.

What actions did we take to address non-compliant products?

Health Canada took several actions in response to non-compliance, including manufacturer notifications, product seizure, voluntary forfeiture, voluntary detention or the issuance of stop sale letters, as outlined in Table 1 Non-compliant products sold in retail stores and Table 2 Non-compliant products sold online in Annex 1 below. Stop sale letters were issued to the manufacturers of products with non-compliant labelling.

Compliant products can be found in Table 3 Compliant products in retail stores and Table 4 Compliant products sold online in Annex 1 below.

Who is responsible for health and safety?

Health and safety is the collective responsibility of industry, healthcare professionals, retailers, consumers, government, and other stakeholders.

Manufacturers of medical devices have the primary responsibility for the safety and effectiveness of the health products they manufacture, sell, import or distribute to the Canadian public. They must comply with all Canadian legislative and regulatory requirements. A manufacturer must obtain a device licence and label its products properly before advertising or selling any Class II, III, or IV device in Canada.

Manufacturers of Class I medical devices must hold a valid Medical Device Establishment Licence (MDEL) to manufacture, sell, import or distribute medical devices in Canada.

Importers and distributors of medical devices must hold a valid Medical Device Establishment Licence (MDEL) to import and sell medical devices in Canada. They must ensure the medical device(s) they are importing or distributing meet the regulatory requirements.

Healthcare professionals, including individuals working in the retail sites selling decorative contact lenses, should ensure that the medical devices they buy have been authorized for sale in Canada and the importer or distributor holds a valid MDEL. This information can be found in the Medical Devices Active Licence Listing or Medical Device Establishment Licence Listing.

Healthcare professionals are encouraged to report to Health Canada any problems or incidents related to the use of medical devices and other health products by using Health Product Complaint Form (FRM-0317), or by calling 1-800-267-9675.

Although Retailers do not require an establishment license, they may only sell licensable health products that have been authorized for sale by Health Canada.

Health Canada uses a number of compliance and enforcement tools to monitor and verify that regulated parties comply with relevant requirements under the Food and Drugs Act (Act) and MDR. Where non-compliance is identified, Health Canada may take steps to mitigate the risk to Canadians by working with industry, issuing product recalls or public communications, or seizing products. The primary objective of Health Canada's compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention.

What can consumers do?

It is important to buy only licensed decorative contact lenses or other medical devices and make yourself aware of any potential health risks. Consumers may check if a class II, III or IV medical device has a valid licence by:

• looking it up in the Medical Devices Active Licence Listing (MDALL)
• calling 1-800-267-9675

If you are having any problems with your vision due to the use of decorative contact lenses (e.g. corneal abrasions, allergic reactions, vision impairment), please contact your healthcare professional.

Consumers are encouraged to report to Health Canada any problems or incidents related to the use of medical devices and other health products by using the Health Product Complaint Form (FRM-0317), or by calling 1-800-267-9675.

For more information, please refer to the following links:

• Drug and health products available in Canada
• Health Product Complaint Form (FRM-0317)
• Recalls and safety alerts
• Medical Devices Regulations
• Safe Medical Devices in Canada
• Medical Devices Active Licence Listing
• Medical Device Establishment Licence Listing
• Risks of Buying Medical Devices from the Internet
• Compliance and Enforcement Policy for Health Products (POL-0001)

Annex 1

• Internet Retailer
  • 1800 Contacts
  • Contacts Express
  • Face Paint Supplies
  • Global Lens
  • Save on Lens
  • Contact for Less
  • Clearly
  • Oya Costumes
  • Primal Contact lenses
  • Primal Contact lenses
  • Don's Hobby Shop & theatrical Supplies
  • Geo Medical Contact Lens
  • Perfect Lens
  • Contact Lenses Canada