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Raindrop near vision inlay recalled
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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.
Perspective
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John A. Hovanesian, MD, FACS
The recall announcement for the Raindrop near vision inlay by Optics Medical (formerly ReVision Optics) is not surprising, given the October 2018 FDA warning that the company issued, instructing surgeons not to implant the device because of long-term safety concerns. The concept of near vision correction with corneal inlays still has much merit, however. CorneaGen, with its Kamra inlay, has achieved very positive long-term clinical results globally, although sales have fallen short of expectations, and Presbia’s Microlens will also hopefully come to market in the U.S. in the coming months. The problems with the Raindrop inlay from Optics Medical may be related to the hydrogel implant material or the depth of implantation (shallower than the Kamra) or both. According to company officials, Optics Medical will re-engineer the implant and seek re-approval after addressing these valid concerns. This may take a few more years. Meanwhile, a growing range of presbyopia treatments, both pharmacologic and surgical, will compete with these corneal inlays for patients in a growing market for presbyopia correction.
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