enVista is a new Glistening-free, hydrophobic acrylic IOL from Bausch + Lomb.
Exceptional quality of vision
No glistenings were reported at any time in controlled clinical studies
Glistenings are prevented and material stability enhanced by:
Hydrating the lens to equilibrium water content so that it will neither gain nor lose water
Packaging the lens in 0.9% saline solution to eliminate fluid exchange with the aqueous humor
Abrasion resistance is increased due to improved surface durability
Hydrophobic properties are maintained over time
nhanced contrast sensitivity; uniform power, center to edge; and better vision quality are delivered by Bausch + Lomb aspheric, aberration-free Advanced Optics
Designed to minimize PCO
Stability and advanced control
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INDICATIONS:
Indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed by an extracapsular cataract extraction method. The lens is intended for placement in the capsular bag.
WARNINGS:
Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:
1. Recurrent severe anterior or posterior segment inflammation or uveitis.
2. Patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases.
3. Surgical difficulties at the time of cataract extraction, which might increase the potential for complications (eg, persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss).
4. A distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible.
5. Circumstances that would result in damage to the endothelium during implantation.
6. Suspected microbial infection.
7. Children under the age of 2 years are not suitable candidates for intraocular lenses.
8. Patients in whom neither the posterior capsule nor zonules are intact enough to provide support.
PRECAUTIONS:
Do not attempt to resterilize the lens as this can produce undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens at a temperature greater than 43°C (110°F). DO NOT FREEZE. Do not autoclave the intraocular lens. Do not reuse the lens. It is intended for permanent implantation. If explanted, sterility and proper function cannot be assured. For complete physician labeling information, refer to the enVista™ product package insert.
- For health care professional use only -