The FAMHP wants to notify ophthalmologists and patients of a safety report from the American government, the Food and Drug Administration (FDA) on the ocular implant Raindrop Near Vision Inlay from the manufacturer Revision Optics. At this time there is no information that the ocular implant was also distributed in Belgium.
The Federal Agency for Medicines and Health Products (FAMHP) was informed of a very high incidence of corneal opacification (“corneal haze”) linked to the use of the device Raindrop Near Vision Inlay from the manufacturer Revision Optics. This device may be marketed by the manufacturers RVO 2.0 and Optics Medical. The implant is intended for patients with presbyopia.
The competent American authority, the Food and Drug Administration (FDA), has published a safety report that advises to no longer implant the device and recommends performing regular follow-ups on the patients with the implant.
The manufacturer has stopped producing the product. The product was distributed in at least the following European countries: Slovakia, France, the Czech Republic, the United Kingdom, the Netherlands and Ireland. We have no confirmed information that the device was also distributed in Belgium, but considering the free traffic of medical devices in Europe, it is possible that the product was indeed sold and implanted in Belgium.
Incidents with medical devices must be reported by doctors to the FAMHP. The incidents can be reported via www.fagg.be/nl/gezondheidszorgbeoefenaar.
Patients are advised to contact their doctor if they have questions or problems.