The FDA released a safety communication regarding the Raindrop near vision inlay after a post-approval study found 75% of patients with the inlay developed haze in any location within the cornea.
The FDA recommended that the Raindrop near vision inlay, brought to market by the now defunct ReVision Optics, not be implanted in any patients moving forward, and those who have the inlay should undergo increased monitoring with their physician. The FDA is working with the device owner, RVO 2.0, which is doing by business as Optics Medical, to collect (Read more...)
Uncategorized