The RxSight Light Adjustable Lens and Light Delivery Device is intended to be used for patients who have undergone cataract surgery. The surgery involved the natural lens of the eye being replaced with an artificial lens (intraocular lens or IOL). Following surgery, patients regularly have to wear glasses due to refractive errors causing the artificial lens to blur the patient’s vision.

The RxSight IOL is made of a unique material that reacts to UV light, which is delivered by the Light Delivery Device around three weeks after surgery. Patients receive three or four light treatments over a period of 1-2 weeks. Patients must wear protective eyeglasses from the time of the cataract surgery to the end of the light treatments to protect the new lens from UV light.

The FDA evaluated a clinical study of 600 patients to assess the safety and effectiveness of the device. The clinical study showed that patients on average saw an improvement in their vision six months after the procedure, without glasses compared to a conventional IOL. Six months after surgery, 75% of patients also had a reduction in astigmatism.

Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat at the FDA’s Center for Devices and Radiological Health, said: “Until now, refractive errors that are common following cataract surgery could only be corrected with glasses, contact lenses or refractive surgery. This system provides a new option for certain patients that allows the physician to make small adjustments to the implanted lens during several in-office procedures after the initial surgery to improve visual acuity without glasses.”