Indications and Important Safety Information
enVista™ Monofocal IOL
INDICATIONS: enVista™ is indicated for use in adult patients for visual correction after cataract removal. Cataract surgery is not completely risk-free. Complications may occur as a result of the removal of your cataract whether or not an intraocular lens is implanted. Complications of cataract surgery range from minor, usually temporary side effects, to sight threatening complications. Fortunately, significant sight threatening complications are extremely rare and include, but are not limited to: infection, hemorrhage, and retinal detachment. People with existing medical conditions such as diabetes and chronic eye infections are at a higher risk of developing complications. The risks of implantation with the enVista™ IOL include the same risks that exist for all cataract surgery with IOL implantation. The long term safety and effectiveness of this lens have not been proven. The safety of the enVista IOL has not been substantiated in patients with preexisting conditions.
This is not all you need to know. Please talk to your doctor about risks, benefits and whether this procedure is right for you.
enVista™ Toric Monofocal IOL
INDICATIONS: enVista™ Toric IOL is indicated for use in adult patients with astigmatism after cataract removal. Astigmatism means that your eye is more egg-shaped than round. Cataract surgery is not completely risk-free. Complications may occur as a result of the removal of your cataract whether or not an intraocular lens is implanted. Complications of cataract surgery range from minor, usually temporary side effects, to sight-threatening complications. Fortunately, significant sight-threatening complications are extremely rare and include, but are not limited to: infection, hemorrhage, and retinal detachment. People with existing medical conditions such as diabetes and chronic eye infections are at a higher risk of developing complications. The risks of implantation with the enVista™ Toric IOL include the same risks that exist for all cataract surgery with Toric IOL implantation. The long term safety and effectiveness of this lens have not been proven. The safety of the enVista™ Toric IOL has not been substantiated in patients with preexisting conditions.
This is not all you need to know. Please talk to your doctor about risks, benefits and whether this procedure is right for you.
enVista Aspire™ IOL
INDICATIONS: The enVista Aspire™ IOL is indicated for use in patients for visual correction after cataract removal.
COMPLICATIONS: Cataract surgery is not completely risk-free. Complications may occur as a result of the removal of your cataract whether or not an intraocular lens is implanted. Complications of cataract surgery range from minor, usually temporary side effects, to sight-threatening complications. Fortunately, significant sight-threatening complications are extremely rare. They include, but are not limited to: infection, hemorrhage, and retinal detachment. People with existing medical conditions such as diabetes and chronic eye infections are at a higher risk of developing complications.
The risks of implantation with the enVista Aspire™ IOL include the same risks that exist for all cataract surgery with IOL implantation. The long term safety and effectiveness of this lens have not been proven. The safety of the enVista Aspire™ IOL has not been substantiated in patients with preexisting conditions.
This is not all you need to know. Please talk to your doctor about risks, benefits and whether this procedure is right for you.
enVista Aspire™ Toric IOL
INDICATIONS: The enVista Aspire™ Toric IOL is indicated for use in patients for visual correction, including correction of astigmatism, after cataract removal.
COMPLICATIONS: Cataract surgery is not completely risk-free. Complications may occur as a result of the removal of your cataract whether or not an intraocular lens is implanted. Complications of cataract surgery range from minor, usually temporary side effects, to sight-threatening complications. Fortunately, significant sight-threatening complications are extremely rare. They include, but are not limited to: infection, hemorrhage, and retinal detachment. People with existing medical conditions such as diabetes and chronic eye infections are at a higher risk of developing complications.
The risks of implantation with the enVista Aspire™ Toric IOL include the same risks that exist for all cataract surgery with IOL implantation. The long term safety and effectiveness of this lens have not been proven. The safety of the enVista Aspire™ Toric IOL has not been substantiated in patients with preexisting conditions.
This is not all you need to know. Please talk to your doctor about risks, benefits and whether this procedure is right for you.
enVista Envy™ IOL and enVista Envy™ Toric IOL
INDICATIONS: The enVista Envy™ and enVista Envy™ Toric IOLs are multifocal, or more specifically, trifocal IOLs, designed for patients with cataracts. They are intended to replace the natural lens in adult patients after the cataract has been removed. The IOLs provide improved intermediate and near vision, while providing similar distance vision compared to a monofocal IOL. The enVista Envy™ Toric IOL also corrects astigmatism.
WARNINGS AND PRECAUTIONS: Some visual effects may be expected, such as halos or glare, issues in dim light conditions, and other visual symptoms regardless of lighting conditions. As with all IOLs, there is a possibility that visual symptoms may be significant enough that a patient may request removal of the IOL. • Contact your eye doctor immediately if you have any of the following symptoms after surgery: a significant decrease in vision; double vision persisting more than a few days; a significant increase in pain in the implanted eye; significant itching, redness, and/or watering of your eye; significant eye discharge; or increased sensitivity to light. • Vision may be poorer in dim or low-contrast conditions than with a monofocal IOL. Take extra care in activities that require good vision in dimly lit environments, like driving at night. • Before surgery, your eye doctor will check if you have any eye diseases. Tell your eye doctor about any eye problems or conditions. If your eye is not healthy, you may not get the full benefit of the enVista Envy™ / enVista Envy™ Toric. • The enVista Envy™ Toric IOL has not been evaluated in a clinical study. The effects of astigmatism remaining after surgery was simulated in a clinical study for patients implanted with the non-Toric enVista Envy™ IOLs. If you have a greater amount of astigmatism after surgery with the enVista Envy™ Toric IOL, you may need eyeglasses to see clearly. • Before surgery, ask your eye doctor to provide you with the enVista Envy™ / enVista Envy™ Toric Patient Information Brochure booklet, which contains risks and benefits of surgery with the IOL.
POTENTIAL RISKS OF CATARACT SURGERY: As with any surgery, there are risks associated with cataract surgery and IOL implantation. This is unrelated to the lens you choose. Cataract surgery complications are rare, but may include inflammation, infection, bleeding, swelling, drooping eyelid, dislocation of the artificial lens, retinal detachment, increased eye pressure (glaucoma), secondary cataract, and injury to the eye. The problems could be minor, temporary, or they could last permanently. There is a small chance that your vision could be made worse by the operation.
This is not all you need to know. Please talk to your doctor about risks, benefits and whether this procedure is right for you.