Линзы интраокулярные: линзы интраокулярные гибкие акриловые однокомпонентные:

Țară: Belarus

Limbă: rusă

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

Disponibil de la:

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

Clasă:

изделия медицинского назначения

Produs de:

Johnson & Johnson Surgical Vision

Data de autorizare:

2021-03-16

Caracteristicilor produsului

Page 1 of 16
IFU IN ENGLISH AND RUSSIAN FOR THE IOL MODEL PCB00
Rx Only
Device Description
The TECNIS® 1-piece lens is an ultraviolet-light absorbing posterior
chamber intraocular lens (IOL) which
compensates for corneal spherical aberrations. Accommodation will not
be restored. It is designed to be
positioned in the lens capsule where the lens should replace the
optical function of the natural crystalline lens.
AMO TECNIS® 1-piece IOLs incorporate a proprietary wavefront-designed
aspheric optic with a squared
posterior optic edge designed to provide a 360-degree barrier. The
edge of the optic has a frosted design to
reduce potential edge glare effects. The image quality of the TECNIS®
optic is illustrated in Figure 1.
The AMO TECNIS® 1-piece lenses are preloaded and preassembled in the
TECNIS iTec Preloaded Delivery
System to provide a sterile, controlled, convenient, and touch-free
method of delivering these lenses into the eye.
The TECNIS iTec Preloaded Delivery System reduces the number of steps
required to prepare the IOL for
insertion into the eye, when compared to a non-preloaded device. The
TECNIS® 1-Piece IOL in the TECNIS iTec
Preloaded Delivery System is available in the full diopter range (5.0
D to 34.0 D) and is compatible with
microincision surgical techniques.
Sodium hyaluronate (HA) used in the cartridge coating is produced by a
microbiological fermentation method.
Indications for Use
AMO TECNIS® 1-piece lenses are indicated for the visual correction of
aphakia in adult patients in whom a
cataractous lens has been removed by extracapsular cataract
extraction. These devices are intended to be
placed in the capsular bag.
Precautions
Do not resterilize the lens or the TECNIS iTec Preloaded Delivery
System. Most sterilizers are not equipped to
sterilize the soft acrylic material and the preloaded inserter
material without producing undesirable side effects.
Do not store the device in direct sunlight or at a temperature under
5°C (41°F) or over 35°C (95°F). Do not
autoclave the device.
Do not