Federal regulators warn that three out of every four patients who received a Raindrop corneal inlay may suffer from hazing and other vision problems, resulting in a recommendation that the eye implants no longer be used.
In a safety communication this week, the FDA raises concerns about a risk of corneal haze associated with the Raindrop Near Vision Inlay, which may result in blurry vision or glare, which may be severe in some cases.
The Raindrop corneal inlay was developed by ReVision Optics, and approved by the FDA in 2016. The implant is a microscopic hydrogel disc meant to improve vision in the place of eyeglasses or contact lenses. ReVision went out of business earlier this year, and the Raindrop inlay is now owned by RVO 2.0, doing business as Optics Medical.
According to the FDA, a post-marketing study of 150 patients found that 75% of patients suffered corneal haze somewhere in their vision within five years of receiving the implant. However, 42% suffered central corneal haze and more than 23% opted to have their Raindrop implant removed. A third of the removals were due to corneal haze.
“At the current time, FDA is recommending that patients should not receive the Raindrop Near Vision Inlay device,” the agency warned patients. “If already implanted with the device, be sure to keep your regularly scheduled appointments with your eye care provider. You should seek sooner evaluation if you have or develop any new or bothersome visual symptoms such as blurry vision or glare. Your physician will determine appropriate treatment options based on the results of an evaluation.”
The FDA also issued recommendations for eye care providers, suggesting they do not implant Raindrop Inlays, carefully monitor patients who have received the device or who have already had it removed, and contact Optics Medical by calling 949-330-6511 for instructions on how to return any unused inlays to the company.
The agency indicates it is working with Optics Medical on a plan to collect the remaining devices and will communicate new information when it is available.
Those who have suffered corneal haze or other vision problems after receiving a Raindrop Near Vision Inlay are urged to issue a report to the FDA through the MedWatch adverse event reporting program.