FDA Approves Rayner’s RayOne EMV IOL
Rayner’s RayOne EMV fully preloaded non-diffractive IOL has received FDA approval.
RayOne EMV was developed in collaboration with renowned surgeon Professor Graham Barrett, president of the Australasian Society of Cataract & Refractive Surgeons.
Dr. Mariano Royo, Director of Ophthalmology at the Hospital San Rafael in Madrid and Director of the Ophthalmic Institute of Madrid, shared his clinical results of 22 eyes of 11 patients implanted with RayOne EMV measured at 6 months post-op. Dr. Royo reported that 100% of his patients that received RayOne EMV achieved spectacle independence in the distance and intermediate range. The average reading aid at 33 cm was reported to be +1.5 D, and one in three patients had functional near vision without the need for spectacles.1
RayOne EMV is a cost-effective solution for patients when diffractive IOLs may be cost prohibitive or if there are concerns about dysphotopsia.
“Following approval of our RayOne and RayPRO platforms in 2019 we have been steadily increasing our investment in the USA to be one of our most important markets worldwide,” Tim Clover, Rayner CEO, said in a company news release. “The approval of RayOne EMV is important as it allows surgeons to offer patients a new option which has been tried and tested in thousands of patients around the world”
Patient outcomes for RayOne EMV can be tracked using RayPRO, a free contactless telehealth solution that collects 3 years’ worth of Patient Reported Outcomes after cataract or refractive surgery.
References
1 Royo, M. RayOne EMV and TECNIS Eyhance: A Comparative Clinical Defocus Curve. Data on file. 2021.