Health Canada — Medical Devices · Canada · 2023-03-10 · Type II
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Reported risk: Since the end of November 2022, Nidek has received reports from EU countries about elevated intraocular pressure after implantation of Eyecee One Preloaded and Eyecee One Crystal Preloaded. Concerned about the possibility of a similar trend occurring in other countries, Nidek decided to the suspension of use of these devices as a precautionary measure, until results of the investigation are available, to all countries in the world where the affected device are marketed, including Canada. Recall start date: February 03, 2023
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