The TGA said the decision to remove Neutrogena’s Visibly Clear Light Therapy Acne Mask and Activator came after consulting with Johnson & Johnson Pacific. The product is also being withdrawn from the market.
Potential retinal damage
The reusable non-sterile device was intended for home-use to treat mild to moderate facial acne. The product comprises an acne face mask and detachable corded ‘activator’. It delivers a combination of red and blue light via light-emitting diodes (LEDs).
According to the regulatory body, this feature was identified to have the potential to cause retinal damage for a “small subset of potentially susceptible people”, including those with certain eye-related disorders such as 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,” said TGA.
Other potential adverse events that may be associated with the use of this device include eye pain, eye discomfort, eye irritation, tearing, blinding, blurring of vision, seeing spots or flashes and other changes in vision, it added.
The TGA has advised Australian consumers to reach out to J&J or visit Neutrogena’s Australian website, which has set up a page for consumers to obtain a refund.
It also advised health professionals to discontinue using the light therapy mask and to report any adverse effects.
Erring on the side of caution
Neutrogena issued a statement attributing its decision to remove the product from shelves to caution and stressing the safety of the product.
The device claims to use red and blue LED light to reduce inflammation and blocks the proliferation of P. Acnes bacteria respectively.
“Our decision to recall this product is being made out of an abundance of caution. The Neutrogena Light Therapy Acne Mask is safe for use by the general population when used once per day as directed. Reports of visual effects associated with the use of the Neutrogena Light Therapy Acne Mask are rare, generally mild and transient,” said the brand.
Neutrogena’s Visibly Clear Light Therapy Acne Mask and Activator launched in 2016 for around US$40 as an affordable alternative to other LED masks in the market.
The mask was developed by beauty start-up La Lumiere under the name illuMask™ Anti-Acne Light Therapy Mask.
According to clinical results, over 93% of users of the illuMask saw overall skin improvement in as little as two weeks. The number of inflammatory acne lesions was reduced by 100%, while the number of non-inflammatory lesions was reduced by over 73%.
J&J acquired La Lumiere and its asset and relaunched illuMask under the Neutrogena brand and won rave reviews as well as awards.
The success prompted the company to launch its Light Therapy Acne Spot Treatment, a similar device targeted for spot treatments. This product is still available for purchase on the brand’s Australian site and is not part of the recall.