Raindrop near vision inlay recalled
A recall of the Raindrop near vision inlay has been issued by RVO 2.0 due to an increased risk of corneal haze, according to an FDA notice.
RVO 2.0, which is doing business as Optics Medical, owns the device, which was approved in 2016 and originally brought to market by the now-defunct ReVision Optics.
A safety communication from the FDA issued in October 2018 recommended the Raindrop inlay stop being implanted after a post-approval study found 75% of patients experienced corneal haze.
The Class I recall affects all lots of unused Raindrop near vision inlays. Physicians are to immediately stop using the inlay in patients and return any unused product to Optics Medical c/o the UPS Store, 26895 Aliso Creek Road #B-1049, Aliso Viejo, CA 92656.
Patients who have received the inlay are to keep any regularly scheduled appointments with eye care providers and seek earlier evaluation if blurry vision or glare develops, the FDA said.