INFINITE VISION OPTICS RECEIVES CE-MARK FOR NEW GENERATION LENS SYSTEM - PreciSight®
Updated: Jun 4, 2020
STRASBOURG, FRANCE, 10 January 2018
InfiniteVision Optics SAS (www.infinitevisionoptics.com) today announced it received the CE-mark approval (Conformité Européene) for the PreciSight® dual lens, docking station system in December 2017.
The PreciSight® lens system is made up of 2 parts - the base plus the front optic. The front optic is slotted into the base optic. If needed, the front optic can be exchanged, either due to unhappiness with the use of the inserted lenses or due to a change in the patient’s eyesight over time.
PreciSight® from InfiniteVision Optics provides the surgeon with unlimited flexibility to ensure the highest possible quality result and so create a happy patient.
“The CE-mark approval is a key milestones in getting the Precisight® dual lens system into the market. The CE-mark approval will allow surgeons to offer the new generation of Multi Component Intraocular Lenses to their patients. This will ensure they achieve their vision target, either following cataract surgery or as part of a Clear Lens Exchange procedure“, said Carsten Laue, CEO of InfiniteVision Optics.
The CE-mark enables the company to market and sell the PreciSight® lens system in the European Economic Area (EEA). The mark signifies that PreciSight® was assessed to meet high safety, health and environmental requirements. Early in 2017 InfiniteVision Optics already received the ISO 13485:2016 certification, an international quality standard for medical devices.
About InfiniteVision Optics Founded in 2010, InfiniteVision Optics developed the PreciSight® intraocular lens system that allows the adjustment of the front intraocular lens throughout the patient’s life when needed. Through a minimally invasive secondary procedure the risk associated with full lens explantation is considerably reduced. This proprietary docking station system provides surgeons with a solution to achieve the best possible refractive outcome. They can provide the patient with solutions to refractive and medical changes throughout their lifetime. These changes cannot be predicted at the time of the initial medical procedure. InfiniteVision Optics is based in Strasbourg, France.