Линзы интраокулярные: линзы интраокулярные гибкие акриловые однокомпонентные:

Country: Բելառուս

language: ռուսերեն

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

MAH:

Johnson & Johnson Surgical Vision, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

class:

изделия медицинского назначения

manufactured_by:

Johnson & Johnson Surgical Vision

authorization_date:

2021-03-16

SPC

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IFU IN ENGLISH AND RUSSIAN FOR THE IOL MODEL ZKB00
RX ONLY DESCRIPTION:
The TECNIS® multifocal foldable acrylic 1-piece lens, Model ZKB00, is
an ultraviolet light-absorbing posterior
chamber intraocular lens (IOL). It is designed to be positioned in the
lens capsule where the lens should replace
the optical function of the natural crystalline lens. The TECNIS®
multifocal foldable acrylic 1-piece lens incorporates
a proprietary wavefront-designed aspheric optic with a squared
posterior edge designed to provide a 360-degree
barrier. The edge of the optic has a frosted design to reduce
potential edge glare effects.
The lens incorporates a diffractive multifocal optic pattern designed
to provide both near and distance vision and
thereby reduce spectacle dependency. The light distribution between
the distance and near focus is approximately
50/50. The labeled power of the lens is the distance power. The near
power represents a +2.75 diopter add in actual
lens power. However, accommodation will not be restored.
INDICATIONS FOR USE:
The TECNIS® multifocal foldable acrylic 1-piece intraocular lens is
indicated for primary implantation for the visual
correction of [1] aphakia in adults with and without presbyopia in
whom a cataractous lens has been removed by
phacoemulsification and [2] aphakia following refractive lensectomy in
presbyopic adults who desire improved
uncorrected near, intermediate, and distance vision and increased
spectacle independence across a range of
distances. The intraocular lens is intended to be placed in the
capsular bag.
PRECAUTIONS:
1. Prior to surgery, the surgeon must inform prospective patients of
the possible risks and benefits associated with
the use of this device and provide a copy of the patient information
brochure to the patient.
2. There were no patients 21 years old or younger included in the
clinical study of parent lens TECNIS® Multifocal
IOL, Model ZM900 (N=348); therefore there are insufficient clinical
data to demonstrate safety and effectiveness
in this age gr