enVista Intraocular lens (IOL)

enVista IOL for cataract surgeryYou have cataracts. Your doctor has a great way to correct your vision.

Cataracts are a natural part of the aging process and will eventually develop in all of us. In fact, cataract surgery is the most commonly performed procedure in the United States with over 3 million procedures annually.

As you grow older, the lens in your eye can stiffen, harden and become cloudy. Since the lens is no longer as flexible or as clear as it used to be, the eye can't focus light properly. This makes it difficult to see as clearly as you once did. Luckily, cataracts have become a "normal" problem to rectify. In an outpatient procedure, your ophthalmologist can replace your eye’s lens with an artificial lens, called an intraocular lens (IOL), resulting in a dramatic restoration of your sight.

Today's advancements in medical procedures allow eye surgeons to correct your cataracts using the best technologies available. In many cases, cataract surgery may reduce the need for eye glasses. It is important to understand that since everyone's vision, expectations, and lifestyles differ, it is difficult to determine how much you will be dependent on glasses after surgery.

enVista is designed to not only treat your cataracts, but to also provide you with the best possible quality of vision. In addition, the enVista IOL is made of an advanced, next-generation material designed to provide long term clarity.

Key Features & Benefits

  • Sharp focus - for clearly defined images
  • Clear vision - advanced material stays clear inside the eye

Safety Information

Cataract surgery is one of the most common surgical procedures performed; however, as with all surgeries there are warnings, precautions and risks that you should be aware of. 

WARNINGS: 

  1. Your eye doctor may not be able to implant the enVista IOL into your eye if you have complications during surgery. Depending on your specific surgical complications your doctor may or may not be able to implant a different IOL during the same surgical procedure.

  2. Contact your eye doctor immediately if you have any of the following symptoms while using the antibiotic eye crops prescribed by your doctor: itching, redness, watering of your eyes, sensitivity to light. These symptoms could indicate a potential serious eye infection.


PRECAUTIONS

  1. As with any surgical procedure, there is risk involved. Possible complications from cataract surgery include infection, damage to the lining of the cornea, separation of the retina from the layer of tissue at the back of the eye (retinal detachment), inflammation or swelling inside or outside the eye, damage to the iris (the colored part of your eye), and an increase in eye pressure.

  2. Tell your doctor if you have been diagnosed with any eye disease.

  3. Avoid any activity that could harm your eye while you are recovering from surgery. For example, avoid any activities where objects can come in contact with or put pressure on the eyes, such as Tennis or Scuba Diving.


POTENTIAL RISKS: There are risks associated with cataract surgery. Because it is surgery it 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. You may have reactions to medicines that may be prescribed to you after your eye surgery and side effects could include redness, scratchiness of the eye, and sensitivity to light. Possible complications from cataract surgery include infection, bleeding, inflammation, tissue damage, tissue swelling of the front or back on the eye, or an increase in eye pressure. If your lens is not in the correct position, your vision may also be affected and the normal flow of fluid within the eye may be blocked. Your vision may not improve or may get worse if complications occur. You may require additional surgery to treat these side effects.

Is this product right for you?

Condition(s)


The enVista IOL is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag. Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: 1. 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 that increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss). 4. Any 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 . 8. Patients in whom neither the posterior capsule nor zonules are intact enough to provide support. The safety and effectiveness of the enVista IOL have not been substantiated in patients with preexisting ocular conditions and intraoperative complications. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more these conditions; vitreous loss (significant), anterior chamber bleeding (significant), uncontrollable positive intraocular pressure. Patients with preoperative problems such as corneal endothelial disease, abnormal cornea, macular degeneration, retinal degeneration, glaucoma, and chronic drug miosis may not achieve the visual acuity of patients without such problems. Potential complications accompanying cataract or implant surgery may include, but are not limited to the following: corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, transient or persistent glaucoma, and secondary surgical intervention. Secondary surgical interventions include, but are not limited to: lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, and retinal detachment repair. For a complete storage and handling information and for physician labeling information, refer to the enVista product package insert.


SUR/EVA/15/0006
 

From WebMD

Eye Conditions & Treatments