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For manufacturers reporting adverse incidents with intraocular lenses under the vigilance system.
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
As with all products, the MHRA will keep its safety under close review.
The MHRA is aware of cases of increased intraocular pressure in patients recently implanted with EyeCee One preloaded and EyeCee One Crystal preloaded intraocular lenses (IOLs), which are manufactured by NIDEK and distributed by Bausch + Lomb U.K. Ltd.
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