देश: बेलारूस
भाषा: रूसी
स्रोत: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Cutting Edge SAS, ФРАНЦИЯ
изделия медицинского назначения
Cutting Edge SAS
2022-03-18
EN INTRAOCULAR LENS DESCRIPTION: The LuxSmart intraocular lens (IOL) is a single-piece ultraviolet (UV) absorbing posterior chamber IOL developed to replace the natural crystalline lens in pseudophakic adult patients. The LuxSmart IOL has aspheric optics. The lens is provided sterile and is designed to be folded prior to insertion in the eye and implantation in the capsular bag. The preloaded intraocular LuxSmart lens is supplied with an Accuject Pro Delivery System to provide a touch-free method of delivery of the lens into the capsular bag. The LuxSmart IOL is supplied in 2 different models – Models LuxSmart Crystal or LuxSmart. See label on the cardboard box for type of the lens. PHYSICAL CHARACTERISTICS: Lens / Haptic Material Model LuxSmart Crystal: Foldable hydrophobic acrylic copolymer containing a UV absorber. Model LuxSmart: Foldable hydrophobic acrylic copolymer containing a UV absorber and a blue light filtering chromophore. Material Characteristics Index of Refraction when wet at 21°C: 1.544 Index of Refraction when in the eye at 35°C: 1.540 Spectral Transmittance Model LuxSmart Crystal: 10% transmittance at 393.5 nanometers for +20.0 diopter IOL. Model LuxSmart: 10% transmittance at 397 nanometers for +20.0 diopter IOL. See FIG. 6 with chart’s X-value = Wavelength (nm) and Y-value = % Transmittance Optic Type Models LuxSmart Crystal and LuxSmart: Aspheric Powers +00.00 to +34.00 Diopters Dimensions Body Diameter: 6.0 mm; Overall Diameter: 11 mm Haptic Angle: 0° Lens Orientation The IOL is to be implanted with the anterior side of the lens facing up towards the anterior side of the eye. The orientation of the IOL can be verified by visual inspection of the lens. As illustrated in FIG. 5, when the orientation features are top right (A) and bottom left (B), you are facing the anterior side of the lens. INDICATIONS: The LuxSmart posterior chamber lens is indicated for primary implantation for the visual correction of aphakia in adult patients. The lens is designed for implantation in the capsular पूरा दस्तावेज़ पढ़ें