FDA Risk & Benefits

Potential Complications

Any surgery, including refractive surgery, carries some risk of complications which includes the
risks of dry eye syndrome, which can be severe; the possible need for glasses or contact lenses after surgery; visual symptoms including halos, glare, starbursts, and double vision, which can be debilitating; and the loss of vision.
Patients should understand the common risks associated with any refractive eye surgery, as well as the risks associated with the Visian Implantable Collamer Lens (ICL) implant procedure. Consult with your doctor for a more thorough explanation of possible complications.
• Common complications of refractive eye surgeries
• Common complications of corneal surgeries
• Common complications of Visian ICL implantable lenses
Many of these potential complications are shared by any refractive procedure, including LASIK and contact lens implants.

Overcorrection or Undercorrection

The most common complication of refractive eye surgery is either overcorrection or undercorrection of the refractive error. Skilled eye surgeons are meticulous in their measurements while preparing for surgery; however their measurements may not be exact. Undercorrection is easily fixed with a follow up procedure such as a repeat LASIK or PRK procedure or with the insertion of a replacement Visian ICL. Patients may also choose to continue wearing glasses or contact lenses.


Since the eye is being physically manipulated during these types of surgeries, a small risk of infection does exist. While not common, eye infections after surgery can cause anything from a delay in the healing process to serious eye damage, including visual acuity loss.

Halos/Night Glare

The most commonly reported side effects of refractive surgery on the cornea are glares surrounding lights at night and halo effects. Sometimes the effects are barely noticeable. Other patients find that they severely limit their sight. Severe cases of halo or night glare can often be corrected with a second procedure; however the surgery may only serve to lessen the effects without totally eliminating them.
Visual Acuity Loss
An extremely rare complication of refractive eye procedures is the loss of visual acuity caused by permanent damage to the eye.

Corneal Surgery Complications

Corneal surgery such as LASIK and PRK are achieved by surgically removing a small portion of corneal tissue in order to re-shape the cornea and improve the eye’s ability to focus.

Dry Eye

Dry eye is becoming more and more of a concern with ophthalmologists when it comes to performing LASIK procedures. Many patients choose to undergo LASIK because pre-operative dry eye makes wearing contact lenses uncomfortable. As many as 75% of LASIK patients may experience dry eye prior to undergoing surgery, and of those who do not, just under 60% may experience dry eye after the procedure. Pre-existing dry eye may actually become worse after LASIK surgery.
Corneal Flap Complications

Some complications that can arise during LASIK surgery have to do with the corneal flap that is cut on the surface of the eye. The flap can be cut too thick or too thin, or it may be irregular. If epithelial cells migrate underneath the flap, a condition called Diffuse lamellar keratitis (DLK) can also occur. These types of complications are not a problem with Visian ICL implantation because the cornea is not touched.

Visian ICL Complications

There are some specific complications that can occur with Visian ICL surgery that do not occur with PRK or LASIK. A consultation with your ophthalmologist will allow you to discuss in detail all potential complications.

Natural Lens Damage
Upon insertion of the Visian ICL into the eye, the risk exists that the implantable lens can touch the eye’s natural lens and cause damage to it. This can create opacity in the lens, which must be corrected with surgery. The complication occurs in less than 1% of Visian ICL recipients. The most serious cases of natural lens damage will require the natural lens to be completely removed and replaced with a synthetic alternative.

Complications of Iridotomy

Shortly before implanting the Visian ICL, your eye surgeon will perform a laser eye procedure known as an iridotomy. A YAG-laser is used to create one or two tiny openings at the edge of the iris. While complications of the procedure are rare, they could include damage to the cornea or lens, inflammation, bleeding, scar formation, or temporary increased intraocular pressure.
Increase in Pressure Inside the Eye
The intraocular pressure inside the eye may increase as a result of the surgery. This pressure imbalance is treated either with medications or additional surgery.

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