The FDA has issued a Class I recall of the Raindrop Near Vision Inlay, according to a March 5 post on its website.1 The decision came after the results of a post-approval study showed 75% of patients developed corneal haze.
The 2mm inlay, made of medical-grade hydrogel plastic, is designed to be implanted in the patient's non-dominant eye through a laser-cut flap in the cornea. Its unique design essentially changes the curvature of the cornea itself to mimic the effect of a multifocal lens.2
The Raindrop—the second implant for presbyopia to make it to market—was approved in June 2016. However, its parent company, Revision Optics, shuttered in January 2018.2 The inlay was indicated strictly for patients who have not had cataract surgery.
The FDA recommends any patients with the device implanted seek evaluation if they develop any haze, blurring or glare.
1. FDA. RVO 2.0, Inc. recalls raindrop near vision inlay due to risk of increased risk of corneal haze. Medical Device Recalls. www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm632670.htm. March 5, 2019. Accessed March 7, 2019.
2. Thompson V. Kamra inlay and corneal implants for presbyopia. All About Vision. www.allaboutvision.com/visionsurgery/corneal-inlays-onlays.htm. February 2018. Accessed March 7, 2019.