The Food and Drug Administration approved the Raindrop Near Vision Inlay, a device implanted into the cornea of one eye to improve close up vision.
The device, produced by Revision Optics in Lake Forest, Calif., is the second FDA-approved corneal implant to correct near vision in patients who have not had cataract surgery and the first implantable device that changes the shape of the cornea to improve vision.
The Raindrop Near Vision Inlay is a clear disc made of hydrogel material that looks like a contact smaller than the eye of a needle. The device is inserted into the patient's non-dominant eye and creates a steeper surface that helps the eye focus on near objects or print.
In a recent Phase 3 clinical study of 373 patients, 95 percent of patients were able to see with 20/40 vision or better at near distances a year after the device was implanted.
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