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FDA recalls Raindrop Near Vision Inlay

14/11/2018By Myles Hume
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The US Food and Drug Administration (FDA) has recalled the Raindrop Near Vision Inlay implant after it was found to have caused corneal hazing in several patients.

It serves as more bad news for its now-defunct manufacturer ReVision Optics, which closed in February. At the time it described Raindrop as “a good product”, and blamed a funding shortfall of US$50 million (AU$69 m) for closing its doors.

The Raindrop Inlay, now owned by Optics Medical, is a transparent, curved hydrogel disc smaller than the eye of a needle. The device is designed for implantation into the cornea of one eye to treat presbyopia, and has been available in Australia since 2014.

According to the FDA notice, 75% of patients in a post-approval surveillance study developed corneal hazing, mainly due to inflammation.

“The FDA is advising that eyecare providers not implant Raindrop inlays and is working with Optics Medical to have all remaining product on the market recalled. Raindrop Inlays are no longer being distributed in the US,” a notice on the FDA website said.

In 2016, the FDA approved Raindrop on the back of a prospective, non-randomised clinical study. This is despite 16% (60 of 373) of patients complaining of central corneal haze two years into the study.

As a result, a condition was placed on approval, demanding the manufacturers needed to continue studying patients for at least five years. This has led to the recent findings and subsequent FDA notice.

The FDA has issued the safety communication to patients implanted with the device, optometrists and ophthalmologists.

It advised that 113 of 150 patients enrolled in the study experienced haze within the cornea within a five-year period. Twenty-two patients developed their first episode of haze 60 months after the device was implanted.

Corneal haze was also a significant reason for device removal. Of the 150 patients, 35 (23.3%) had their device removed.

Of these 35 patients, 11 had the device removed due to corneal haze, and 10 had the device removed due to unresolved inflammation. One patient first developed haze six months after removal of the device; while some patients continued to have corneal haze even after the device was removed.

“At the current time, the FDA is recommending that patients should not receive the Raindrop Near Vision Inlay device. If already implanted with the device, be sure to keep your regularly scheduled appointments with your eyecare provider,” the FDA notice read.

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“You should seek sooner evaluation if you have or develop any new or bothersome visual symptoms such as blurry vision or glare.”

Ophthalmologists should monitor patients who either still had the implant, and those who have had it removed.

The FDA is currently working with Optics Medical on a plan to collect remaining devices that have already been distributed, and will continue to gather and evaluate data related to this issue in order to communicate new information as needed.

More reading: Raindrop maker announces business closure

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