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Raindrop Inlay: Australian recall after ‘corneal hazing’

28/11/2018By Myles Hume
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A recall notice has been issued for the Raindrop Corneal Inlay in Australia amid concerns over corneal hazing.

Raindrop’s Australian distributor, Device Technologies, issued the ‘hazard alert’ recall action on November 23 and has also recommended that ophthalmologists monitor both implanted and explanted patients. The Therapeutic Goods Administration (TGA) told Insight approximately 24 Australian patients had undergone surgery for the corneal implant to correct presbyopia, however, it had not yet been subject to adverse event reports.

The action comes in the wake of the US Food and Drug Administration (FDA) banning further use of the device, also known as the Raindrop Near Vision Inlay, last month. An extended study discovered it had caused hazing in 75% of participants, including in patients who had already had it removed.

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.

A notice published on the TGA website said: “Device Technologies Australia has been made aware of an increased risk of corneal haze (a type of cloudiness in the cornea due to inflammation) associated with use of the Raindrop Corneal Inlay device.

“People who undergo implantation of the Raindrop Near Vision Inlay device are at risk for the development of corneal haze that can affect clear vision. Haze can cause blurry vision or glare by clouding the cornea, or by changing the focusing power of the eye.

"The impact of haze on the patient’s vision is dependent on the severity of haze and its location in the cornea.”

A TGA spokesperson said Device Technologies’ recall letter would be sent to all customers who had been supplied the product, including implanting surgeons. Details of this recall have been published on the TGA website.

According to the US FDA’s recall notice, 113 of 150 patients enrolled in one study experienced corneal hazing within a five-year period.

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Twenty-two patients developed their first episode of haze 60 months after the device was implanted, and corneal haze was a significant reason for device removal. Of the 150 patients, 35 (23.3%) had their device removed.

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