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| Chaffin Luhana LLP

Raindrop Near Vision Inlay WarningIn a recent safety communication, the FDA warned patients and eye doctors about problems associated with the Raindrop Near Vision Inlay, a medical device that helps improve near vision. The device has the potential to increase the risk of corneal haze, a type of cloudiness in the cornea caused by inflammation. The FDA has warned eye care providers not to implant any more of the devices and is working with manufacturer ReVision Optics, d.b.a. Optics Medical, to recall all the remaining devices on the market.

Meanwhile, the company closed its doors back in February 2018, citing business growth problems, and halted its distribution of the Near Vision Inlay back in January 2018.

Raindrop Near Vision Inlay Designed to Improve Near Vision

Most people experience some level of close-vision deterioration around the mid-40s and after, because of a condition called “presbyopia.” The condition occurs when the lens of the eye, which is like a camera lens that changes shape to help focus light on the back of the eye, become less agile. This makes it harder for the eye to focus on close objects and can make tasks like reading and doing close-up work more difficult.

The FDA approved the Raindrop Near Vision Inlay in 2016 to help improve presbyopia and offer patients an alternative to eyeglasses or contacts. The first product of its kind, the device is similar to a contact lens, yet only as big as the eye of a needle. Doctors implant it into the cornea where it creates a steeper surface, making up for the lens’ struggle to change shape, and helping patients focus on near objects.

After the product was on the market, though, ongoing studies showed that it could increase risk of corneal haze.

Device Associated with Increased Risk of Corneal Haze

When the FDA first approved the Inlay, it did so on the basis of a clinical study that showed it was effective. The two-year results of that study, however, showed a small risk of central corneal haze in patients. As a condition of approval, the FDA required the manufacturer to perform a post-approval study designed to follow patients from the original study for at least five years.

Corneal haze is a condition in which the cornea becomes inflamed, causing blurry vision or a glare. Though early results of the study showed a small risk, later results were more concerning. The most recent data from the ongoing study, showed that the rate of corneal haze was 42 percent (63 of 150 patients). Twenty-two of the patients didn’t develop the haze until five years after implantation. To date, 35 patients from that study had to have the device removed because of corneal haze or inflammation.

Of additional concern is the fact that though corneal haze can be treated with steroids, these medications also increase the risk of eye pressure, eventual glaucoma, and cataracts. The FDA has warned eye doctors not to implant the device in any new patients, and to carefully monitor patients who already have the device implanted for signs of corneal haze.

There is some question about the reasons behind Revision Optics’ decision to go out of business, considering they were aware back in January of the increasing problems with their device. According to EyeWire News, Sarah Cannon, Vice President of Global Marketing at Revision Optics, said the decision was purely a business one and had nothing to do with Raindrop.

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