Safety Information

Potential Risks and Complications of the Visian ICL

As with any type of surgery, the Visian ICL carries the risk of complications. To help educate prospective patients, the following information outlines some of the most common risks of the Visian ICL implant procedure and those of corneal refractive surgery. For detailed information regarding all possible complications, please ask a qualified Visian ICL surgeon. All refractive procedures, from LASIK surgery to implantable contact lens insertion, share possible complications.

Implantation of the Visian ICL is a surgical procedure, and as such, carries potentially serious risks. Please review this brochure and discuss the risks with your ophthalmologists.

· First Week after Visian ICL Surgery: complications reported included: Visian ICL removal and reinsertions (2.5%), shallowness of the front chamber of the eye (0.4%), need for peripheral iridectomy (0.2%), temporary corneal swelling (edema,11.4%) and transient inflammation in the eye or iritis (19.5%).

· Complications After 1st Week: increase in astigmatism (0.4%), loss of best corrected vision (1.9%), clouding of the crystalline lens (cataract,1.4%), loss of cells from the back surface of the cornea responsible for the cornea remaining clear (endothelial cell loss, 8.9% at 3 years), increase in eye pressure (0.4%), iris prolapse (0.2%), cloudy areas on the crystalline lens that may or may not cause patient symptoms (lens opacities, 2.7%), macular hemorrhage (0.2%), retinal detachment (0.6%), secondary Visian ICL related surgeries (replacements, repositionings, removals, removals with cataract extraction, 3.1%), subretinal hemorrhage (0.2%), too much or too little nearsightedness correction (2.0% off by more than 2 D), and additional YAG iridotomy (3.2%). Page 10 of 29 Only 2 eyes (0.5%) lost > 2 lines of best corrected vision (with glasses) compared to 6.5% of eyes that gained > 2 lines of visual acuity with glasses. Of note, only 6.5% of eyes lost 1 line of best corrected visual acuity while 38.0% of eyes gained 1 line.

Potential Complications are not limited to those reported during the clinical study.

The following represent potential complications/adverse events reported in conjunction with refractive surgery in general: conjunctival irritation, acute corneal swelling, persistent corneal swelling, endophthalmitis (total eye infection), significant glare and/or halos around lights, hyphema (blood in the eye), hypopyon (pus in the eye), eye infection, Visian ICL dislocation, macular edema, non-reactive pupil, pupillary block glaucoma, severe inflammation of the eye, iritis, uveitis, vitreous loss and corneal transplant.

Overall, the higher the amount of nearsightedness before the Visian ICL, the higher the incidence of complications/risks after Visian ICL surgery.

ALTERNATIVE TREATMENTS

· The types of eye surgeries that are available to correct nearsightedness are Radial Keratotomy (RK), Photorefractive Keratectomy (PRK), Laser Assisted in situ Keratomileusis (LASIK) and Phakic Intraocular Lens surgery. The Implantable Collamer Lens is a type of phakic intraocular lens. These surgeries may not meet the vision requirements for some careers, such as military service.

· Eye surgeries can be categorized by those that change the shape of the front surface of your cornea, which is the clear layer at the front of your eye (including RK, PRK and LASIK) and intraocular lens surgery that involves the insertion of a lens within the eye. Page 11 of 29

· RK uses a scalpel to make fine cuts in the cornea.

· PRK and LASIK use a laser to reshape the cornea. For LASIK, an instrument called a microkeratome first cuts a thin flap of tissue from the front of your cornea. This corneal flap is folded back and the laser removes tissue under the flap to change the shape of the front surface of your eye (cornea). Then the flap is put back in place for the eye to heal.

Contraindications

You should NOT have Visian ICL surgery if you:

· Have a narrow anterior chamber angle as determined by a special examination by your eye doctor, or if your doctor determines that the shape of your eye is not adequate to fit the Visian ICL (anterior chamber depth less than 3 mm)

· Are pregnant or nursing

· Do not meet the minimum endothelial cell density for your age at the time of implantation as determined by your eye doctor

Warnings

· Two iridotomies (holes in the extreme outer edge of the colored portion of the eye) must be performed 90º apart using a yttrium aluminum garnet (YAG) laser at between 2 to 3 weeks before implantation of the Visian ICL.

· The long-term effects on the corneal endothelium have not been established. You should be aware of potential risk of corneal edema (swelling), possibly requiring Page 12 of 29 corneal transplantation. Periodic checks of your endothelium are recommended to monitor the long-term health of the cornea

· The long-term rate of cataract formation (decrease clarity of your natural crystalline lens) secondary to implantation / removal and/or replacement of the Visian ICL are unknown.

· The potential of the lens to alter the pressure in your eye and the long-term risks of glaucoma, peripheral anterior synechiae and pigment dispersion are unknown.

Precautions

1. Patients with higher amounts of nearsightedness had worse results with lower effectiveness and higher risk of complications.

2. The effect of pupil size on visual symptoms is not known.

3. The relationship between the Visian ICL and future lens opacities and retinal detachment is undetermined.

4. There currently is a lack of long-term data to assess cataract formation and cataract progression following removal and/or replacement of the lens.

5. The effectiveness of ultraviolet absorbing lenses in reducing the incidence of retinal disorders has not been established.

6. The safety and effectiveness of the Visian ICL for the correction of moderate to high nearsightedness has NOT been established in patients:

· with unstable or worsening nearsightedness

· with history or clinical signs of iritis/uveitis

· with diabetic retinopathy Page 13 of 29

· with glaucoma

· with history of previous eye surgery

· with serious (life-threatening) non-ophthalmic disease

· with progressive sight-threatening disease other than nearsightedness

· with a diagnosis of ocular hypertension(high eye pressure)

· with insulin-dependent diabetes

· with pseudoexfoliation

· with pigment dispersion

· with greater than -20 D of nearsightedness; greater than 2.5 D of astigmatism

Are you a good candidate for Visian ICL?

If you are considering Visian ICL surgery for nearsightedness you must:

• be between the ages of 21 and 45

• have between –3D and –20D of nearsightedness

• understand that the Visian ICL is indicated for the correction of nearsightedness between –3D and ≤ -15D and the reduction of nearsightedness between > -15D and –20D

• have an anterior chamber depth of 3.0 millimeters or greater

• have a minimally acceptable endothelium cell density which will be determined by your physician

• have a refraction that has been stable for at least 1 year

• understand the risks and benefits of Visian ICL for nearsightedness surgery compared to other available treatments for nearsightedness

• be able to lie flat on your back

• have no known allergies to any of the medications that your physician may discuss will be used before, during and after your surgery

• not be pregnant or nursing

• understand that prior to implantation of the Visian ICL you will need to undergo YAG iridotomy 2 to 3 weeks before Visian ICL surgery

• be willing to sign an Informed Consent Form provided by your doctor.

What to expect during the Visian ICL procedure

Before the Surgery

Before surgery, your doctor needs to determine your complete medical and eye history and check the health of both your eyes. This exam will determine if your eyes are healthy and if you are a good candidate for Visian ICL surgery. This examination will include a measurement of the inner layer of your cornea (endothelium).

Tell your doctor if you take any medications, have any eye conditions, have undergone previous eye surgery, have any medical conditions or have any allergies. Ask your doctor if you should eat or drink right before the surgery. You should also arrange for transportation since you must not drive immediately after surgery. Your doctor will let you know when your vision is good enough to drive again.

Two to Three Weeks before Surgery

Two to three weeks before your Visian ICL surgery, your eye doctor will schedule to perform YAG laser iridotomy to prepare your eye for implantation of the Visian ICL. This is necessary to make sure that the fluid flows properly from the back chamber to the front chamber of the eye to prevent a buildup of pressure within the eye after Visian ICL surgery. The doctor will usually apply numbing drops to the eye and make tiny openings in the colored portion of the eye with a laser beam. Usually this doesn’t affect your ability to drive home after this procedure but check with your eye doctor.

After the iridotomy procedure, your eye doctor will prescribe eye drops for you to use. It is important that you follow-up all medication instructions. Your physician will instruct you to discontinue the use of these medications before the day of surgery.

The Day of Surgery

The day of surgery, your eye doctor will place eye drops in your eye to dilate (enlarge) the pupil in your eye.

Once your pupil is fully dilated, your eye doctor will put numbing eye drops in your eye and/or use an injection of numbing medication and ask you to lie on your back on the treatment table/chair in the treatment room. Your eye doctor may discuss alternative anesthetic/sedation options with you before surgery.

A small incision is made into your cornea and the Visian ICL is inserted and positioned in its proper position in the eye as illustrated in Diagram 3 at the beginning of this booklet. The entire procedure will usually take approximately 20 to 30 minutes or less.

After the surgery is complete, your doctor will place some eye drops/ointment in your eye. For your eye protection and comfort, your doctor may apply a patch or shield over your eye. The procedure is painless because of the numbing medication. It is important that you do not drive yourself home and make arrangements before the day of surgery for transportation home.

The First Days after Surgery

Your physician will need to see you the day after surgery for a check up which will include monitoring the pressure in your eye.

You may be sensitive to light and have a feeling that something is in your eye. Sunglasses may make you more comfortable. Also, your eye may hurt. Your doctor can prescribe pain medication to make you more comfortable during the first few days after the surgery. If you experience severe pain in the eye, please contact your doctor immediately. You will need to use antibiotics and anti-inflammatory eye medications (eye drops/ointments) in the first week.

IMPORTANT: Use the eye medications as directed by your eye doctor. (Your results may depend upon your following your doctor’s instructions).

DO NOT rub your eyes especially for the first 3 to 5 days. If you notice any sudden decrease in your vision, you should contact your doctor immediately.

Long Term Care: In a small number of cases Visian ICL replacement and/or removal may become necessary. If your physician removes the Visian ICL, you will lose the benefit of your nearsightedness correction. After Visian ICL surgery it is important that you follow your physician’s recommendations for eye care and follow-up visits.

Questions to ask your Doctor

You may want to ask the following questions to help you decide if Visian ICL surgery for nearsightedness is right for you:

• What are my other options to correct my nearsightedness?

• Will I have to limit my activities after surgery and for how long?

• What are the benefits of Visian ICL surgery for my amount of nearsightedness?

• What vision can I expect in the first few months after surgery?

• If Visian ICL surgery does not correct my vision, what is the possibility that my eyeglasses would need to be stronger than before? Could my need for eyeglasses increase over time? Could I undergo a different type of eye surgery for the correction of my vision?

• How is Visian ICL surgery likely to affect my need to wear eyeglasses or contact lenses as I get older?

• Will my eye heal differently, if injured after implantation of the Visian ICL?

• Should I have Visian ICL surgery in my other eye?

• How long will I have to wait before I can have surgery in my other eye?

• What vision problems might I experience if I have an Visian ICL only in 1 eye?

Discuss the cost of surgery and follow-up care needs with your doctor. Most health insurance policies do not cover eye surgery for the correction of nearsightedness.

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