OTTAWA, ON, Feb. 3, 2023 /CNW/ -

Summary

• Product: Intraocular lenses when used to replace a patient's natural lens of the eye are only licensed in Canada to treat cataracts. They are not licensed to replace lenses in patients without cataracts, and come with risks.
• Issue: Medical device – product safety
• What to do: Consult your eye care professional if you have concerns with your eyes and have had the natural lens of your eye replaced with an intraocular lens but did not have cataracts. Report adverse effects or complaints involving medical devices. 

Affected products

Intraocular lenses used to replace lenses in patients without cataracts.

Issue

Health Canada is warning that intraocular lenses are not licensed to replace a patient's natural, healthy lens (without cataracts) and that their use for this purpose comes with risks that may outweigh the benefits.

Entities such as surgical eye clinics and professional organisations are advertising procedures that would use intraocular lenses to replace the natural, clear lens in patients without cataracts (known as a clear lens exchange). The procedure is promoted to correct near sightedness, far sightedness or astigmatism, and as an alternative to wearing glasses, contact lenses or laser eye surgery.

Some advertising may leave patients with the false impression that the devices have been evaluated by Health Canada for safety and effectiveness for this use. 

Health Canada reviews medical devices to assess their safety and effectiveness before licensing them for sale in Canada. An intraocular lens is a tiny artificial lens that is surgically implanted inside the eye. There are several intraocular lenses licensed in Canada. They are only labelled:

• to replace the natural lens in patients suffering from cataracts (cloudy lenses). For these patients, the benefits of cataract removal may outweigh the risks of surgery.
• to be implanted without removing the natural lens in patients who do not have cataracts to improve vision. For these patients, the risks associated with lens removal do not apply. This procedure can also be reversed if medically necessary.

Health Canada has not received evidence from device manufacturers to date demonstrating that the benefits of replacing a patient's natural, clear (healthy) lens with an intraocular lens outweigh the risks.

The procedure may not correct vision 100% and may still result in the need for glasses or less-than-perfect vision. For patients with a healthy clear natural lens with no cataract, the benefits of a clear lens exchange in reducing or removing reliance on glasses or contact lenses, or avoiding laser eye correction, may not outweigh the short- and long-term risks related to the lens replacement surgery, such as increased risk of retinal detachment, or any unknown long-term risks of the device itself. In addition, cataracts are a condition usually associated with older patients. As a result, longer-term negative impacts of lens replacement may not have been evaluated or taken into consideration for younger patients.

The decision to recommend the use of a licensed intraocular lens device outside of the Canadian labelled use is at the discretion of the eye care professional, and is considered "off-label use." In using a health product off-label, health care professionals apply their clinical knowledge of the product in consideration of the patient's individual medical needs, to determine whether the benefits outweigh the risks for that patient.

Risks related to intraocular lenses and the clear lens exchange procedure may include:

• vision loss
• eye infection
• bleeding of the eye
• increased eye pressure
• severe eye inflammation
• development of debilitating visual symptoms
• development of a retinal tear, swelling or detachment

Even with treatment, some of these complications can lead to permanent blindness.

If your eye care professional has recommended a clear lens exchange, you should be made aware of all of the risks and benefits of the device and the procedure before agreeing to the procedure.

What is being done 

Advertising medical devices for indications not approved by Health Canada is illegal. Health Canada notified the Canadian Ophthalmological Society (COS) of its concerns related to the advertising of intraocular lenses for clear lens exchange. The COS reviewed its Guidelines for Refractive Surgery Advertising and sent a reminder to its members.

Health Canada will continue to monitor the safety of intraocular lenses, as it does for all medical devices on the Canadian market, to identify and assess potential harms. Should new health risks be identified, Health Canada will take appropriate action.

Alert / recall type: Public Advisory 
Category: Health products – medical devices 
Published by: Health Canada

Également disponible en français

SOURCE Health Canada