Acne

Safety recall for acne phototherapy mask


The TGA has issued a recall and safety warning for a ‘light therapy mask’ promoted for home phototherapy treatment of acne

The Neutrogena Visibly Clear Light Therapy Acne Mask and Activator has been withdrawn because of potential risk of eye damage from its LED blue light emissions, and patients should be advised to stop using it, the regulator say

The ‘Acne Mask’ delivers a combination of red/blue light to the skin but the TGA alert says that exposure to blue light may cause “varying degrees of retinal damage that could be irreversible and could accelerate peripheral vision impairment or loss.”

“If you are treating a patient who uses Neutrogena Visibly Clear Light Therapy Acne Mask and Activator, inform them of this issue and advise them to cease using the device immediately and to report any adverse effects,” the safety advisory says.

Launched in 2016, and promoted as a ‘dermatologist in-office technology’ the device has been popularised by celebrities as a way of self-treating mild-to-moderate acne. It comprises a reusable non-sterile ‘acne face mask’ and detachable corded ‘activator’.

The low level LED blue light emissions are claimed to have antibacterial (against P. acnes) and anti-inflammatory benefits if used once daily for 10 minutes.

However the manufacturer Johnson & Johnson now says it is recalling the product “out of an abundance of caution” following reports of retinal damage.

“For a small subset of the population with certain underlying eye conditions, as well as for users taking medications which could enhance ocular photosensitivity, there is a theoretical risk of eye injury,” it states on its website.

According to the TGA safety advisory: “it has been identified that, for a small subset of potentially susceptible people (including people with certain eye-related disorders e.g. retinitis pigmentosa, ocular albinism, other congenital retinal disorders), repeated exposure may cause varying degrees of retinal damage that could be irreversible and could accelerate peripheral vision impairment or loss.”

“Other potential adverse events that may be associated with use of this device are eye pain, eye discomfort, eye irritation, tearing, blinding, blurring of vision, seeing spots/flashes and other changes in vision (for example vision colour).”

Consumers are advised to return the products to the place of purchase for a full refund or contact Johnson & Johnson Pacific Consumer Care Centre.

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