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Neutrogena Visibly Clear Light Therapy Acne Mask and Activator
Recall - Potential for eye damage
Consumers and health professionals are advised that Johnson & Johnson Pacific, in consultation with the TGA, is recalling Neutrogena Visibly Clear Light Therapy Acne Mask and Activator. The device is also being withdrawn from the market.
Neutrogena Visibly Clear Light Therapy Acne Mask and Activator is a reusable non-sterile device, intended for home-use to treat mild to moderate acne on the face. The device comprises an ‘acne face mask’ and detachable corded ‘activator’. It delivers a combination of red and blue light via light-emitting diodes (LEDs).
The activator is a small hand-held battery pack that is electronically limited to 30 sessions of 10 minutes each, intended to be used once per day, after which it times out and a new one is to be purchased separately and the mask is re-used.
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).
Information for consumers
If you or someone you provide care for uses the Neutrogena Visibly Clear Light Therapy Acne Mask and Activator, you are advised to stop using the device and contact the Johnson & Johnson Pacific Consumer Care Centre by calling 1800 789 348 or visiting the Neutrogena website to arrange return of the device and a refund. If you have any questions or concerns about the above issue, talk to your health professional.
Information for health professionals
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.
If you have any questions about this issue, contact Johnson & Johnson Pacific on 1800 789 348.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.