FDA: Safety Communication on Raindrop Near Vision Inlay

Editor's Note

The Food & Drug Administration (FDA) on October 23 issued a Safety Communication on the increased risk of corneal haze associated with the Raindrop Near Vision Inlay, which is surgically implanted in the cornea of one eye to improve near vision.

The notice is to alert eye care providers and patients already implanted with the device of the increased risk of corneal haze, which is a cloudiness in the cornea because of inflammation associated with the device.

The FDA is advising that eye care providers not implant the device and is working with Optics Medical to have all remaining devices on the market recalled.