FDA Warns Against Using Raindrop Near Vision Inlay
The FDA today issued an alert about an increased risk for corneal haze in patients with the Raindrop Near Vision Inlay (Optics Medical). The FDA issued the alert after 75% of patients in a postapproval study of the device developed corneal haze, according to a report in Medscape.
The FDA is warning eye care providers not to implant the inlays and is working with Optics Medical to recall all remaining inlays from the market. They are no longer being distributed in the United States.
“People who undergo implantation of the Raindrop Near Vision Inlay device are at risk for the development of corneal haze that can affect clear vision. Haze can cause blurry vision or glare by clouding the cornea, or by changing the focusing power of the eye,” FDA noted in the alert.
Access the FDA warning letter here.