Линзы интраокулярные предзагруженные: линзы расширенного диапазона зрения LuxSmart: модели: LUXSMART™, LUXSMART crystal™

Երկիր: Բելառուս

Լեզու: ռուսերեն

Աղբյուրը: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Հասանելի է:

Cutting Edge SAS, ФРАНЦИЯ

Դաս:

изделия медицинского назначения

Պատրաստված է:

Cutting Edge SAS

Հաստատման ամսաթիվը:

2022-03-18

Ապրանքի հատկությունները

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