They received FDA clearance.
The U.S. Food and Drug Administration has cleared a contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light.
The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology are soft contact lenses indicated for daily use to correct the vision of people with non-diseased eyes who have myopia or hyperopia, according to an announcement posted on the FDA’s website. They can be used by people with certain degrees of astigmatism.
“This contact lens is the first of its kind to incorporate the same technology that is used in eyeglasses that automatically darken in the sun,” said Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health.
The contact lenses contain a photochromic additive that adapts the amount of visible light filtered to the eye based on the amount of UV light to which they are exposed. This results in slightly darkened lenses in bright sunlight that automatically return to a regular tint when exposed to normal or dark lighting conditions.
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For the clearance, the FDA reviewed scientific evidence including a clinical study of 24 patients that evaluated daytime and nighttime driving performance while wearing the contact lenses. The results of the study demonstrated there was no evidence of concerns with either driving performance or vision while wearing the lenses.
The contacts are intended for daily wear for up to 14 days. They should not be used as substitutes for UV protective eyewear.
The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology were reviewed through the premarket notification 510(k) pathway. A 510(k) is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
The FDA granted clearance of the Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology to Johnson & Johnson Vision Care Inc.
