RVO 2.0, doing business as Optics Medical, pulled its Raindrop Near Vision Inlay from the market after post-approval study data showed an increased risk of corneal haze in patients.
Nearly 2,900 units of the transparent, curved hydrogel discs were recalled. The product is smaller than the eye of a needle and is designed to improve a patient’s near vision through implantation in the cornea.
The FDA identified the recall as Class I and recommended against the inlay’s implantation, as it could cause corneal haze, a type of cloudiness caused by inflammation that results in blurry vision or glare.
