Kraj: Białoruś
Język: rosyjski
Źródło: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Johnson & Johnson Surgical Vision, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Johnson & Johnson Surgical Vision
2021-03-16
Page 1 of 12 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 Przeczytaj cały dokument