Visian ICL™ (Implantable Collamer Lens)
For Nearsightedness
Facts You Need To Know About STAAR Surgical’s Visian ICL SURGERY
PATIENT INFORMATION BOOKLET
For Nearsightedness (Myopia) between –3 to –20 Diopterswith 2.5 Diopters or less of Astigmatism

Please read this entire booklet. Discuss its contents with your eye doctor so that you haveall of your questions answered to your satisfaction. Ask any questions you may have before
you agree to this surgery.
Distributed and Manufactured by:
STAAR Surgical Company
1911 Walker Avenue
Monrovia, CA 91016 USA
Tel:(800) 352-7842
FAX: (800) 952-4923

Copyright 2016 by STAAR Surgical Company
This booklet may be reproduced only by a treating physician, for use with patients considering Visian ICL
Surgery. All other rights are reserved.

.
CAUTION: U.S. (Federal) law restricts this device to sale by or on the order of aphysician.

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TABLE OF CONTENTS
1.0 Glossary ........................................................................................................................ 3
2.0 Introduction ................................................................................................................... 8
3.0 What Is Nearsightedness? ............................................................................................. 8
4.0 How Does Visian ICL Correct Nearsightedness? ......................................................... 9
5.0 Other Treatments to Correct Nearsightedness? .......................................................... 12
6.0 Benefits And Risks Of The Visian ICL for Nearsightedness ..................................... 12
7.0 Contraindications ........................................................................................................ 19
8.0 Warnings ..................................................................................................................... 19
9.0 Precautions .................................................................................................................. 22
10.0 Are You A Good Candidate For Visian ICL Surgery? ............................................. 23
11.0 What Should You Expect During Visian ICL Surgery? ........................................... 24
12.0 Questions To Ask Your Doctor ................................................................................ 27
13.0 Self-Test .................................................................................................................... 28
14.0 Clinical Studies ......................................................................................................... 29
15.0 Summary of Important Information .......................................................................... 33
16.0 Patient Assistance Information ................................................................................. 35

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1.0 Glossary
This section summarizes important terms used in this information booklet or that your doctor
may discuss with you. Please discuss any related questions with your doctor.
Acute: Of sudden, rapid onset, usually with notable symptoms.
Acute Corneal Swelling: A sudden swelling of the usually clear front surface of the eye(cornea).
Anisocoria: Unequal pupil size.
Anterior Chamber: Front chamber of the eye; anterior chamber depth is the space between theback of the cornea to the front part of the crystalline lens. Anterior chamber angle is the location
where the cornea and iris meet.
Antibiotic Medication: A drug used to treat or prevent infection. Your doctor may prescribe
this medication after Visian ICL surgery.
Anti-inflammatory Medication: A drug that reduces inflammation or the body’s reaction to
injury or disease. Any eye surgery can cause inflammation. Your doctor may prescribe themedication after Visian ICL surgery.
Astigmatism: A focusing error that results in blurred distant and/or near vision. The cornea ismore curved in some directions than others, and causes light rays to focus at different points
inside the eye. Parts of objects appear clearer than other parts.
Cataract: Opacity, or clouding, of the crystalline lens inside the eye that can blur vision.
Collagen: A gel-like supporting substance found in the cornea, skin and other connective tissueof the body.
Collamer: Hydroxyethyl methacrylate (HEMA)/porcine-collagen based polymer material(STAAR proprietary product).
Conjunctival Irritation: An irritation of the white portion of the eyeball and inner eyelid.
Contraindications: Any special conditions that result in the treatment not being recommended.
Cornea: The clear front layer of the eye that lets light enter. Surgery such as PRK, LASIK and
RK reshapes the cornea to improve distant vision.
Corneal Edema: Abnormal fluid build-up/swelling in the cornea. The condition is usually
temporary after surgery with no significant effect on vision. Persistent corneal swelling may
cause a loss of vision.

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Corneal Endothelium: A thin, single layer of cells on the innermost surface of the cornea,
responsible for keeping the cornea clear. These cells do not reproduce and decrease in number
with age.
Corneal Flap: A thin slice of tissue on the surface of the cornea made at the beginning of a
LASIK procedure. This flap is folded back before the laser shapes the inner layer of the cornea.
Corneal Transplant: Removal and replacement of cornea.
Crystalline Lens: A structure inside the eye that helps to focus light onto the back surface(retina) of the eye.
Cystoid Macular Edema: Swelling of the macula, located in the center of the retina.
Diabetic Retinopathy: Damage to the back surface of the eye responsible for sensing light due
to diabetes.
Diopter: A unit of focusing power, used to describe the amount of nearsightedness andastigmatism of an eye. Abbreviated as “D”.
Double Vision: Seeing multiple images of the object being looked at.
Endophthalmitis: Severe infection or inflammation of the entire eyeball.
Endothelial Cell Loss: A thin, single layer of cells (endothelial cells) on the innermost surfaceof the cornea keeps the cornea clear by pumping water out of it. Normally, these cells slowly
decrease in number as you age. Additional loss of these cells beyond the normal amount canoccur following many kinds of eye surgery. If too many cells are lost, the cornea can become
cloudy, which can decrease vision.
Endothelium: See Corneal Endothelium.
Glare: A harsh or uncomfortable bright light. Glare symptoms are usually caused by adistortion of light that would otherwise be tolerable without the distortion.
Glaucoma: An eye disease usually associated with high eye pressure. Glaucoma damages the
optic nerve of the eye and usually causes a progressive loss of vision.
Halos: Circular flares or rings of light that may appear around a headlight or other lighted
object. This symptom may occur after surgery.
Hyphema: Blood in the front (anterior) chamber of the eye.
Hypopyon: Discharge in the front chamber of the eye.
Implantable Collamer Lens (ICL): A lens made of collagen containing polymer which is
implanted in the eye behind the iris and in front of the crystalline lens in order to correct orreduce nearsightedness. The Visian ICL can be removed.
4Inflammation of the Eye: The eye’s response to injury, infection or irritation which can cause
redness of the eye, pain, blurred vision and/or light sensitivity.
Intraocular Lenses: An artificial lens that is placed in the eye to correct refractive errors suchas nearsightedness.
Intraocular Pressure (IOP): The amount of pressure of the fluid inside your eye.
Iris: Colored part of the eye.
Iris Prolapse: A movement of the colored portion of the eye through a surgical wound to a
position outside the eye.
Iritis: Inflammation in the front (anterior) chamber of the eye.
Laser Assisted In-Situ Keratomileusis (LASIK): A type of eye surgery that uses a device tocreate a thin, hinged flap of tissue on the cornea which is then folded back. A laser then reshapes
the tissue under the flap and the flap is put back on the eye so the tissue heals.
Lens: Natural crystalline lens in the eye which helps focus light properly into the back of theeye.
Lens Opacities: A cloudiness of the crystalline lens.
Macular Degeneration: A reduction in your central vision due to the thinning of a part of yourretina responsible for fine (reading) vision.
Macular Edema: Swelling in the area responsible for fine (reading) vision on the back surfaceof the eye (retina).
Macular Hemorrhage: Bleeding in the area responsible for fine (reading) vision on the backsurface of the eye (retina).
Myopia: A focusing error that results in blurrier vision at distance than near. Myopia is also
called nearsightedness.
Narrow Anterior Chamber Angle: A decrease in the size of the front chamber of the eyewhich could block the flow of fluid from inside of the eye to the outside resulting in a raised eyepressure (glaucoma).
Nearsighted/Nearsightedness: A focusing error that results in blurrier vision at distance thannear. Nearsightedness is also called myopia.
Non-reactive Pupil: A condition where the colored portion of the eye does not get larger orsmaller when light is shined in the eye.
Ocular Hypertension: Increased eye pressure.
Peripheral Anterior Synechiae: Scar tissue at the outer edges of the front chamber of the eye.
5Peripheral Iridotomy: A small hole placed at the outer edge of the colored portion of the eye,usually using an Yttrium Aluminum Garnet (YAG) laser beam.
Persistent: Lasts for a period of time during the study follow-up usually at least until the end of
the study.
Phakic Intraocular Lens: Placement of a man-made lens in an eye that still has its natural
crystalline lens.
Photorefractive Keratectomy (PRK): A type of eye surgery that uses a laser to reshape thefront surface of the eye to improve vision. After the epithelium (outermost layer) of the cornea
is first scraped away, the laser removes tissue from the exposed surface. After the surgery, theepithelium grows back.
Pigment Dispersion: An abnormal release of pigment particles from cells in the eye that could
block the drainage of fluid from the inside to the outside of the eye.
Pseudoexfoliation: A condition where flakes of material can come off the surface of thecrystalline lens and block the drainage of fluid from the inside to the outside of the eye.
Pupil: The black part of the eye; fluctuates in size allowing varying degrees of light into theeye.
Pupillary Block Glaucoma: The inability of fluid to flow from the back chamber of the eye tothe front chamber frequently blocking drainage of fluid out of the eye and raising the pressure in
the eye (glaucoma).
Radial Keratotomy (RK): A type of eye surgery that changes the shape of the front surface ofthe eye by making a special pattern of cuts in the cornea to correct nearsightedness.
Retina: The layer of nerve tissue at the back of the eye that captures images, similar to film in acamera, and sends information about these images to the brain. Light must be focused correctlyon the retina to form clear images.
Retinal Detachment: Separation of the retina from its natural position on the back surface ofthe eyeball.
Subretinal Hemorrhage: Bleeding under the retina.
Uveitis: Inflammation of the middle layer of tissue in the eye.
Viscoelastic: gel-like fluid placed inside the eye during eye surgery to help maintain the shape ofthe eye
Visian ICL: see Implantable Collamer Lens

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Visual Acuity: A measure of the sharpness of vision using a letter chart. Best Corrected Visual
Acuity (BCVA) is the best vision with eyeglasses. Uncorrected Visual Acuity (UCVA) is the bestvision without eyeglasses or contact lenses.
Vitreous Loss: The loss of a clear gel like material from the farthest back chamber of the eyeduring a surgical procedure.
YAG Laser: Yttrium Aluminum Garnet laser beam used in ophthalmology to produce a small
hole at the outer edge of the colored portion of the eye (peripheral iridotomy).

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2.0 Introduction
The purpose of this booklet is to help you decide if you want to have the Visian Implantable
Collamer Lens (ICL) placed in one or both of your eyes to treat your nearsightedness (ormyopia). It is important for you to understand both the benefits and risks of this surgery before
you make a decision. The “Glossary” in this booklet explains the meaning of all words printed initalics. Please read this entire booklet carefully and discuss your questions with a doctor who istrained in Visian ICL surgery.

3.0 What Is Nearsightedness?
Your eye works like a camera. You see objects because your eye focuses light into images.
Both the clear front layer of your eye, called the cornea, and your natural crystalline lens focuses
rays of light onto the back surface of the eye, called the retina. Diagram 1 shows how an eyewith normal vision focuses rays of light onto the retina at the back of the eye.

DIAGRAM 1: NORMAL EYELight focuses on the retina.
Vision is clear.

8Nearsightedness is a focusing error that causes blurrier vision at distance than at near. Light
from an object in the distance focuses in front of the back surface of your eye (retina)
responsible for capturing images, rather than directly on the retina. Your eyeglass prescription
tells your doctor how nearsighted you are. Diagram 2 shows how a nearsighted eye with blurry
vision focuses light at a point in front of the retina.
DIAGRAM 2: NEARSIGHTED EYELight focuses in front of the retina.
Vision is blurry.

Glasses and contact lenses can help your eye focus light properly on the retina.
The Visian ICL can also help your eye focus light properly on the retina.

4.0 How Does Visian ICL Correct Nearsightedness?
The Visian ICL is a lens made from a soft plastic and natural collagen-based material called
collamer. It is similar to lenses that are placed in the eye (intraocular lenses) to correct vision
after cataract surgery. The Visian ICL is placed in the eye through a small cut, and is placed
9behind the colored part of the eye (iris) and in front of the natural lens (crystalline lens). Whenplaced correctly, the Visian ICL focuses light properly on the back surface of your eye (retina).
Diagram 3 shows how light is focused in a nearsighted eye that has been implanted with a
Visian ICL.

DIAGRAM 3: CORRECTION OF VISION AFTER VISIAN ICL SURGERY
Light focuses on the retina after surgery.
Vision is clearer.

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A diopter (D) is a unit of focusing power used to describe the amount of nearsightedness or
focusing error (astigmatism) in the eye. Visian ICL surgery is designed to treat nearsightedness
between –3D to –15D, and reduce nearsightedness up to -20D in eyes with up to 2.5D ofastigmatism. If you have nearsightedness within these ranges, Visian ICL surgery may improveyour distance vision without eyeglasses or contact lenses.
The Visian ICL will not correct any astigmatism you may have. Astigmatism is a focusing errorof the eye that results in blurred vision. In eyes with astigmatism, the clear front layer of the eyethat lets light enter (cornea) is more curved in some directions than others. This causes light rays
to focus at different points inside the eye and some parts of objects will appear clearer than otherparts. Diagram 4 shows how an eye with astigmatism may focus light.

DIAGRAM 4: NEARSIGHTED and ASTIGMATIC EYE

11Visian ICL surgery is permanent as long as the Visian ICL stays in your eye. The Visian ICL canbe removed at a future date. However, the residual effect of the Visian ICL on your eye after it isremoved is not known. If your physician removes the Visian ICL, you will lose the benefit ofyour nearsightedness correction. This means that your vision may not return to what it was likebefore the Visian ICL surgery.

5.0 Other Treatments to Correct Nearsightedness?
Other treatments for nearsightedness include eyeglasses, contact lenses or other eye surgeries.
Eye surgeries available to correct nearsightedness include Radial Keratotomy (RK),Photorefractive Keratectomy (PRK), Laser Assisted in situ Keratomileusis (LASIK) and Phakic
Intraocular Lens implantation (the Visian ICL is a phakic intraocular lens). These surgeries may
not meet the vision requirements for some careers, such as military service. Eye surgeries caneither change the shape of the front surface of the clear layer at the front of your eye (cornea),
including RK, PRK and LASIK, or require the insertion of a lens into the eye. RK uses a surgicalinstrument to make fine cuts in the cornea. PRK and LASIK use a laser to reshape the cornea.
For LASIK, an instrument cuts a thin flap of tissue from the front of your cornea. This corneal
flap is folded back and a laser removes tissue under the flap to change the shape of the cornea.
The flap is then put back in place for the eye to heal.

6.0 Benefits And Risks Of The Visian ICL for Nearsightedness
Benefits
Visian ICL surgery can safely correct nearsightedness between –3D to –15D, and partiallycorrect nearsightedness up to -20D in eyes with up to 2.5D of astigmatism.
If your eyeglass prescription is in these ranges, the Visian ICL may make your distance vision
without eyeglasses or contact lens correction better. Placing the Visian ICL into the eye requires
surgery, and all eye surgery carries potentially serious risks. Please review this booklet anddiscuss the risks with your doctor.

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RisksThis part of the booklet explains the risks of Visian ICL surgery. Information concerning risks
were collected in the following Visian ICL clinical studies for the FDA:1.

FDA Safety and Effectiveness Study of the Visian ICL
In this study, a total of 526 eyes of 294 patients had Visian ICL surgery. Patients were
examined by the study doctor until 36 months (3 years) after surgery in the first part ofthe study, and in the second part of the study, patients returned for visits until 60 months(5 years) or longer after Visian ICL surgery. The study doctors collected information on
the below items:o Additional surgeries;o Cataract formation;o Loss of best corrected vision (BCVA)o Raised pressure inside the eye (intraocular pressure) and damage to the optic
nerve caused by increased pressure in the eye (glaucoma);o Loss of cells on the innermost surface of the cornea (endothelial cells);o Other complications.

2. Patient Survey Study for the Visian ICLThis study collected information on adverse events and complications reported by 1547
patients (2999 eyes) up to 5 years after surgery.

Please see 14.0 Clinical Studies of the Visian ICL for more information about these FDA ClinicalStudies. The major risks that were identified are discussed below.

Additional (Secondary) Surgery
Another surgery to take out, replace or adjust the position of the Visian ICL may be necessary.
You may also need another surgery if you develop a cataract or to lower increased pressure
inside your eye.
FDA Safety and Effectiveness Study of the Visian ICL•

43 out of 526 implanted eyes (8.2%) had another surgery related to the Visian ICL
through 5 to 7 years after implantation:13

o 4 eyes (0.8%) had a second surgery to change the position of the Visian ICL,o 8 eyes (1.5%) had a second surgery to replace the Visian ICL,o 10 eyes (1.9%) had a second surgery to remove the Visian ICL,o one eye (0.2%), had both a replacement and removal of the Visian ICL.
In the cases of Visian ICL removal, the reason for removal was associated withcataract surgery.
•20 out of 526 implanted eyes (3.8%) had a second surgery to treat raised pressure inside
the eye:o 17 (3.2%) had another hole placed in the extreme outer edge of the colored
portion of the eye (peripheral iridotomy) to reduce the pressure,o 3 (0.6%) eyes, had another surgery to remove the remaining gel-like fluid usedduring eye surgery (viscoelastic fluid).

Patient Survey Study for the Visian ICL•

126 out of 2999 implanted eyes (4.2%) had another surgery to reposition, replace orremove the lens through 5 years after implantation.

Cataract Formation
After Visian ICL surgery, patients have increased risk of developing cloudiness of the naturallens (cataract), including risk of a cataract that may need surgery. The risk of a cataract
continues to rise with each year that the Visian ICL is in the eye. Because of this, you should see
your doctor regularly for an eye exam to check you for cataracts. The long term risk of acataract and additional surgery may be higher in older patients and those with higher levels ofnearsightedness (myopia). Cataracts that affect vision may require surgery to remove thecataract. In this case, both the Visian ICL and the cataract is removed and another intraocularlens is implanted, just as is done in any routine cataract surgical procedure.
FDA Safety and Effectiveness Study of the Visian ICL•

45 out of 334 eyes (13.5%) that were seen at 5-7 years after surgery, developed someform of cataract.

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Patient Survey Study for the Visian ICL•

154 of 2999 eyes (5.1%) reported cataract development up to 5 years after Visian ICL
surgery.

The long-term risk of cataract beyond 7 years is unknown. If your doctor recommends
cataract surgery, both the Visian ICL and the cataract is removed and another intraocularlens is implanted, just as is done in any routine cataract surgery.

Loss of best corrected vision
FDA Safety and Effectiveness Study of the Visian ICL•

18 out of 526 eyes (3.4%) in the study lost vision of two or more lines as measured on an eye
chart:o 9 eyes (1.7%) lost vision because of clouding of the natural lens (cataract),o one eye (0.2%) lost vision due to stretching of the eye,o one eye (0.2%) lost vision due to pulling of the retina from its natural position(retinal detachment),o reasons could not be determined for vision loss for 4 eyes (0.8%),o in 3 eyes (0.6%) vision loss was temporary and improved without treatment.

Vision got better in eyes that lost vision due to clouding of the natural lens after cataract surgery.
In 7 of the 18 eyes (1.3% of all 526 eyes in the study) that lost vision of two or more lines in the
study, vision did not get better after 5 or more years after surgery.

Raised intraocular pressure (IOP) and glaucoma development
Normal eye pressure (intraocular pressure or IOP) can vary, but is often considered to be from
10-21 millimeters of mercury (mmHg). An IOP higher than normal is called ocular hypertension
and if left untreated, can cause damage to the optic nerve (glaucoma) and cause permanent vision
loss. Patients with high levels of nearsightedness are also at increased risk of developing
glaucoma.

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FDA Safety and Effectiveness Study of the Visian ICL•

20 out of 526 implanted eyes (3.8%) experienced an increase in eye pressure requiring
treatment beyond just the use of medicine, most often at 1 to 2 days after surgery:o 17 eyes (3.2%) had another hole placed in the extreme outer edge of the colored
portion of the eye (peripheral iridotomy) to reduce the pressure,o 3 eyes (0.6%) had another surgery to remove the remaining gel-like fluid usedduring eye surgery (viscoelastic fluid).

•

14 eyes (2.7%) had an increase in IOP to values greater than 10mmHg higher than before
Visian ICL surgery or to higher than 25mmHg through 5 years or more after surgery,•7 eyes (1.3%) in 4 patients developed damage to the optic nerve (glaucoma) through 5 ormore years after ICL surgery. The first case of glaucoma was diagnosed at 5 months
after Visian ICL surgery and the last case happened at over 6 years (73 months) after
surgery.

Patient Survey Study for the Visian ICL•

47 eyes of the 2999 implanted eyes (1.6%) reports of being treated for increased IOP or
glaucoma up to 5 years after surgery.

Endothelial Cell Loss
A thin, single layer of cells (endothelial cells) on the surface of the cornea closest to the inside ofyour eye, keeps the cornea clear by pumping water out of it. Normally, these cells slowly
decrease in number as you age. Additional loss of these cells beyond the normal amount canhappen after many kinds of eye surgery. If too many cells are lost, the cornea can become
cloudy, which can decrease vision.
Loss of endothelial cells can happen after Visian ICL surgery. Before your surgery, you will
have an eye exam that will help your doctor decide if you are a candidate for Visian ICL surgery.
Patients implanted with the Visian ICL experience some loss of endothelial cells and acontinuing loss of endothelial cells over time that is greater than that expected from aging.

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FDA Safety and Effectiveness Study of the Visian ICL•

13 eyes (11%) of those checked at 5 -7 years from surgery had more than 30%
endothelial cell loss:o 3 of these eyes (2.6%) reported this loss within the first year after surgery. The
timing of the loss for the 3 eyes suggest that the loss may have been caused by thesurgical procedure used to insert the Visian ICL into the eye.
o 10 eyes (8.7%) had endothelial cell loss 5 years or more after surgery.

Patient Survey Study for the Visian ICL•

corneal problems were reported for 5 of the 2999 implanted eyes (0.3%) up to 5 years
after surgery.

Amount of loss can vary, but if loss reaches a critical level, there could be a build-up of fluid or
swelling of the cornea (corneal edema). Corneal edema may require that your cornea beremoved and replaced (corneal transplantation).

Glare and Halos
Glare and halos can be present in patients even if they never had any ocular surgery. If you
currently experience glare and halos, there is a chance that they may be more severe after Visian
ICL surgery.
FDA Safety and Effectiveness Study of the Visian ICL
Glare•

76 out of 526 eyes (14.4%) of patients reported glare before surgery. At 3 years after
surgery, 41 out of 351 eyes (11.7%) of patients reported glare.

•

34 of 351 eyes (9.7%) of patients noted increased glare symptoms at 3 years after
surgery compared to before surgery.

Halos
•

59 out of 526 eyes (11.2%) of patients reported halos before surgery. At 3 years after
surgery, 49 out of 350 eyes (14%) of patients reported halos.

17•

40 of 350 eyes (11.4 %) of patients noted increased halos at 3 years after surgery
compared to before surgery.

Patient Survey Study for the Visian ICLThis study did not collect surveys from patients before their surgery. It is not known how manyof the patients reported glare and halos before Visian ICL surgery.
•glare was reported for 85 out of 2999 (2.8%) implanted eyes up to 5 years after surgery.

•halos were reported for 156 out of 2999 (5.2%) implanted eyes up to 5 years after
surgery.

Other Complications
Other risks associated with Visian ICL surgery may include:•

movement of the colored portion of the eye (iris) through a surgical wound to a position
outside the eye (iris prolapse),•

bleeding in the area on the retina responsible for reading vision (macular hemorrhage),•

bleeding under the retina (subretinal hemorrhage),•increase in focusing error (astigmatism),•

lifting or pulling of the retina from its natural position (retinal detachment),•

unequal pupil size (anisocoria).

Potential complications are not limited to those reported during the clinical study. The following
represent potential complications/adverse events reported with refractive surgery in general:•

irritation of the white portion of the eyeball and inner eyelid (conjunctival irritation),•

temporary severe abnormal fluid build-up/swelling in the cornea (acute corneal swelling)
after surgery that does not cause a loss of vision,•

continuing abnormal fluid build-up/swelling in the cornea (persistent corneal swelling)that may cause a loss of vision,•

partial or total eye infection (endophthalmitis),•significant harsh or uncomfortable bright light (glare) or circular flares or rings of lightthat may appear around a headlight or other lighted object (halos),18

•blood in the eye (hyphema),•discharge in the eye (hypopyon),•

Visian ICL dislocation,•

cyst-like swelling with of the center of the retina with fluid (cystoid macular edema),•condition where the colored portion of the eye does not get larger or smaller when light isshined in the eye (non-reactive pupil),•the inability of fluid to flow from the back chamber of the eye to the front chamber,frequently blocking drainage of fluid out of the eye and raising the pressure in the eye(pupillary block glaucoma),•severe inflammation of the eye,•inflammation in the front part of the eye (iritis),•

inflammation in the middle layer of tissue in the eye (uveitis),•loss of clear gel-like material from the farthest back chamber of the eye during surgery(vitreous loss) and•removal and replacement of the cornea (corneal transplant).

7.0 Contraindications•

You should NOT have Visian ICL surgery if you:•are less than 21 years of age;•have a narrow front (anterior) chamber as measured by a special eye test by your doctor,
or if your doctor finds that the shape of your eye is not adequate to fit the Visian ICL(anterior chamber depth less than 3.0 millimeters);•

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

8.0 Warnings•

Two holes in the extreme outer edge of the colored portion of the eye (peripheral
iridotomies) must be performed 90º apart using a laser at between 2 to 3 weeks before
implantation of the Visian ICL.
19•The long-term effects of the Visian ICL on the thin, single layer of cells on the surface ofthe cornea closest to the inside of your eye, that keep the cornea clear (corneal
endothelium) are not known. In the FDA clinical study with the Visian ICL, some patientshad 30% or greater loss of corneal endothelial cells. You should be aware that a greaterthan normal build-up of fluid or swelling of the cornea (corneal edema) can happen. The
corneal edema may even require that your cornea be removed and replaced (corneal
transplantation). You should see your doctor regularly for an exam to check yourendothelium as long as you have the Visian ICL in your eye(s). This will help your doctor
monitor the long-term health of your cornea.

•

After Visian ICL surgery, patients have increased risk of developing cloudiness of thenatural lens (cataract), including risk of a cataract that may need surgery. The risk ofcataract continues to rise with each year that the Visian ICL is in the eye. Because of this,you should see your doctor regularly for an eye exam to check you for cataracts. Thelong term risk of a cataract and additional surgery may be higher in older patients andthose with higher degrees of nearsightedness (myopia). The long-term risk of a cataract
beyond 7 years is unknown.

•

The potential of the Visian ICL to raise the pressure inside your eye (intraocularpressure) and the long-term risks of the following are unknown:


damage to the optic nerve caused by increased pressure (glaucoma),scar tissue at the outer edges of the front chamber of the eye (peripheral anterior
synechiae), and

abnormal release of pigment particles from cells in the eye that could block thedrainage of fluid from the inside to the outside of the eye (pigment dispersion).

•

There is a part of the eye that fluid flows through when draining from the inside of theeye. After Visian ICL surgery, this drainage area may get more narrow and should bemonitored by your doctor. It is important that you return to the doctor after surgery,according to the schedule that he provides.

•

Patients may develop glare and halos after Visian ICL and patients with glare and halos
prior to surgery may have more severe symptoms after surgery. If your pupil in medium
20light conditions is larger than the optic of the Visian ICL, you may experience glare or
halos after surgery. Discuss with your surgeon whether the size of your pupil might
affect the quality of vision achieved with Visian ICL. See Diagrams 5, 6, and 7 forexamples of the appearance of glare, starburst, and halos.

DIAGRAM 5 – EXAMPLE OF GLAREDIAGRAM 6 – EXAMPLE OF STARBURSTDIAGRAM 7 – EXAMPLE OF HALOS

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9.0 Precautions
1. Patients with higher amounts of nearsightedness had worse results. The Visian ICL wasless effective in correcting nearsightedness and there was a higher risk of complicationsin these patients.
2. The effect of pupil size on visual symptoms is not known.
3. The relationship between the Visian ICL and future cloudiness of the lens (cataract) andlifting or pulling of the retina from its natural position (retinal detachment) is not known.
4. The ability of ultraviolet absorbing lenses to reduce the incidence of retinal disorders has
not been established. Examples of retinal disorders include damage to your eye caused bysun gazing or reduction in your central vision due to the thinning of a part of your retina(macular degeneration).
5. The safety of and ability of the Visian ICL to correct moderate to high nearsightedness
has NOT been established in patients with:•unstable or worsening nearsightedness;•

history or clinical signs of inflammation inside the eye (iritis/uveitis);•damage to the layer of the nerve tissue at the back of the eye that captures images(retina) caused by diabetes (diabetic retinopathy);•

damage to the optic nerve caused by increased pressure in the eye (glaucoma);•with history of previous eye surgery such as removal and replacement of the cornea(corneal transplant) or surgery to repair the layer of the nerve tissue at the back of theeye that captures images (retina) after it has separated from its natural position on theback surface of the eyeball (retinal detachment);•

life-threatening non-ocular disease (e.g., end-stage heart failure or kidney disease);•progressive sight-threatening disease other than nearsightedness;•a diagnosis of high pressure inside the eye (ocular hypertension);•insulin-dependent diabetes;•

flakes of material blocking normal fluid drainage from the eye (pseudoexfoliation);•

abnormal release of pigment inside the eye (pigment dispersion);•greater than -20D of nearsightedness; greater than 2.5D of astigmatism.
2210.0 Are You A Good Candidate For Visian ICL Surgery?
Your doctor will conduct a thorough eye examination to determine if you are a candidate for
Visian ICL surgery. In addition, 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 and no more than 2.5D of astigmatism;•

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 the shape of your eye able to fit the Visian ICL (have an anterior chamber depth of
3.0 millimeters or greater);•have a minimally acceptable density of the thin, single layer of cells (endothelial cells) on
the innermost surface of the cornea, responsible for keeping the cornea clear. If yourdoctor determines that your endothelial cell density is below the minimum level, you will
be at greater risk of swelling of your cornea (corneal edema), possibly requiring removal
and replacement of your cornea (corneal transplantation);•

have written evidence that your nearsightedness has been stable for at least 1 year;•

understand the risks and benefits of Visian ICL for nearsightedness surgery compared toother available treatments for nearsightedness;•

be able to lie flat on your back;•have no known allergies to any of the medications that your doctor may discuss will be
used before, during and after your surgery;•not be pregnant or nursing;•understand that at between 2 to 3 weeks before Visian ICL surgery you will need to haveholes made in the extreme outer edge of the colored portion of the eye (peripheral
iridotomy) using a laser;•

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

23You and your doctor will determine if you are a suitable candidate for the Visian ICL and thefrequency of follow-up required to monitor the health of your eye.

11.0 What Should You Expect During Visian ICL Surgery?
Before the Surgery
Before surgery, your doctor needs to determine your complete medical and eye history and checkthe health of both your eyes. This exam will determine if your eyes are healthy and if you are agood candidate for Visian ICL surgery. This examination will include a measurement of theinner layer of your cornea (endothelium).

If you wear contact lenses, it is very important that you stop wearing them 2 to 4 weeks before
your eye examination and surgery for the doctor to obtain a stable eye measurement. Failure to
do this may lead to suboptimal results of your surgery.

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 isgood enough to drive again.

Two to Three Weeks before Surgery

Two to three weeks before your Visian ICL surgery, your doctor will make two holes in theextreme outer edge of the colored portion of the eye (peripheral iridotomies) 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 andmake tiny openings in the colored portion of the eye (iris) with a laser beam. Usually thisdoesn’t affect your ability to drive home after this procedure but check with your doctor.

24After the peripheral iridotomy procedure, you will be prescribed eye drops for you to use. It is
important that you follow all medication instructions. Your doctor will instruct you to
discontinue the use of these medications before the day of surgery.

The Day of Surgery

On the day of surgery, eye drops will be placed in your eye to enlarge (dilate) the black part ofyour eye (pupil).

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

A small incision is made into the clear front layer of the eye that lets light enter (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.

25

The First Days after Surgery

Your doctor will need to see you the day after surgery to conduct an eye exam 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
eye drop/ointment drugs in the first week to treat or prevent infection (antibiotic) and reduce
inflammation in the eye (anti-inflammatory) 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 after surgery. 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. Visian ICL replacement may be performed if your doctor believes a different
lens may either fit your eye better or provide you better vision. Visian ICL removal may benecessary if you develop a cataract and your doctor recommends surgery. If you need to havecataract surgery, the intraocular lens used to replace your natural crystalline lens can often
correct your nearsightedness.
If your doctor removes the Visian ICL, you will lose the benefit of your nearsightedness
correction. This means that your vision may not return to what it was like before the Visian ICL
surgery. After Visian ICL surgery it is important that you follow your doctor’s recommendations
for eye care and follow-up visits.

2612.0 Questions To Ask Your Doctor
You may want to ask the following questions to help you decide if Visian ICL surgery fornearsightedness 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 quality of 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 myeyeglasses 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 thecorrection of my vision?

•

How is Visian ICL surgery likely to affect my need to wear eyeglasses or contactlenses 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 n Visian ICL only in 1 eye?

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

27

13.0 Self-Test
Are You An Informed And Educated Patient?
Take the test below to see if you can answer the following questions after reading thisbooklet.
True

False

1.

Visian ICL surgery for nearsightedness is the same as laser
surgery.

□□

2.

Visian ICL surgery is risk-free.

□

□

3.

It does not matter if I wear my contact lenses before Visian ICL
surgery when my doctor told me not to wear them.

□

□

4.

After the surgery, there is a good chance that I will depend lesson eyeglasses or contact lenses to see
distant objects.

□

□

5.

There is a risk I may lose some best corrected vision after Visian
ICL surgery.

□

□

6.

It does not matter if I am pregnant or nursing.

□

□

7.

If my doctor finds that I have decreased size of the front chamberof the eye (narrow anterior chamber angles) which could block
the flow of fluid from the inside to the outside of the eye, I am
still a good candidate for Visian ICL surgery.

□

□

8.

The Visian ICL will correct my astigmatism.

□

□

9.

It is important I follow my doctor’s specific instructions
concerning medications.

□

□

10.

My doctor does not need to know about my full medical history(conditions not dealing with the eye).

□□

You can find the answers to Self-Test at the end of Section 15- Summary of
Important Information.

28

14.0 CLINICAL STUDIES
Safety and Effectiveness Study of the Visian ICL for Nearsightedness
A clinical study was conducted to evaluate the benefits and risks of Visian ICL surgery.
The study was conducted in two phases: the first phase lasted three years after surgery tocollect effectiveness and safety information. The second phase involved collection of
more safety data to at least five years after Visian ICL Surgery.

Description of Study Patient Group:•

526 eyes of 294 patients were implanted with a Visian ICL•

Most patients were white (Caucasian) and over half of the patients were female•

Patients ranged from 21 to 45 years of age at time of surgery•

Nearsightedness before surgery ranged between –3D and –20D. The average was –10.06D.

Visual Acuity without Glasses after Surgery:•

Visual acuity measures the sharpness of vision using a letter chart. In the UnitedStates, a visual acuity of 20/40 or better measured on an eye chart is required inmost states to drive a car without glasses or contact lenses. Three years after
insertion of the Visian ICL, 94.7% of eyes in the Visian ICL study saw 20/40 or
better without glasses or contact lenses. Table 1 shows the percent of patients inthe study that had 20/20 or better and 20/40 or better vision without glasses,
measured using an eye chart. The table shows vision at time points after surgery,either for all patients (All Study Patients row) or based on their degree ofnearsightedness before Visian ICL surgery.
Table 1: Visual Acuity* Without Glasses, After Surgery by Range of
Nearsightedness (Myopia) Before Surgery
Lens GroupAll Study Patients≤ -7D of myopia
before surgery

Exam Interval
1 Year
2 Year
3 Year
1 Year
2 Year29

20/20 or Better
65.4%
59.6%
59.3%
76.3%
70.3%

20/40 or Better
96.7%
93.4%
94.7%
98.8%
97.3%

> -7D to -10D
myopia before
surgery> -10D to -15D
myopia before
surgery> -15D myopia
before surgery

3 Year
1 Year
2 Year
3 Year
1 Year
2 Year
3 Year
1 Year
2 Year
3 Year

72.4%
70.0%
64.3%
62.7%
43.3%
37.5%
37.5%
NA%**
NA%**
NA%**

98.3%
96.0%
94.9%
92.8%
93.7%
95.0%
93.8%
NA%**
NA%**
NA%**

*Eyes with range of nearsightedness (myopia) with glasses 20/20 or better before surgery andtargeted for complete correction** No Eyes > -15 D group with this preoperative vision or targeted correction

In the clinical study of the Visian ICL, vision without glasses improved for all eyes
except in those eyes with the most extreme amount of nearsightedness. The strongest
Visian ICL could not completely correct the vision in those eyes. Also, in one eye, theretina separated from its natural position on the back surface of the eyeball (retinal
detachment) and this eye had no change in uncorrected vision compared to before
surgery. Some patients still needed glasses or contact lenses after surgery to view
distant objects.
Patient Satisfaction after Visian ICL Surgery:
Patients in the clinical study were asked to report their satisfaction with the Visian
ICL procedure. Three years after Visian ICL surgery, 92.1% of patients werevery/extremely satisfied and 7.3% were moderately/fairly satisfied with their vision.
Only 0.6% of patients were unsatisfied.

Quality of Vision after Visian ICL Surgery:
Quality of vision reported by patients as very good/excellent improved from 55%
before the Visian ICL to 77% at 3 years after the Visian ICL procedure. Patients
reporting poor/very poor vision dropped in half at 3 years (5.8%) compared to before
the Visian ICL (11.6%).
Patients in the clinical study were asked on a questionnaire to report on the following
symptoms before and 3 years after the Visian ICL procedure. Responses are shown in30

Table 2. More patients rated the following symptoms absent or mild at 3 years
compared to before the Visian ICL: harsh or uncomfortable bright light (glare), nightvision difficulties and night driving difficulties. Percentages of patients reporting
circular flares or rings of light around lighted objects (halos) and seeing multiple
images of the object being looked at (double vision) were similar before the Visian
ICL and at 3 years after surgery.
The clinical study results showed that patients with higher levels of nearsightedness
before the Visian ICL procedure reported more frequent and more severe symptoms
both before and after the Visian ICL procedure.

Table 2: Subjective Patient Symptoms- Compared to Before Surgery
Symptom
Harsh or uncomfortable bright light (Glare)
Circular flares/rings of light around lighted
objects (Halos)
Seeing multiple images of the object being
looked at (Double Vision)
Night Vision
Night Driving Difficulties

Improved
at 3 Years
12.0%

No Changeat 3 years
78.3%

Worsened
at 3 Years
9.7%

79.4%

11.4%

97.2%

1.7%

12.0%

76.0%

12.0%

13.7%

76.1%

10.1%

9.1%
1.1%

Patients in the Visian ICL safety and effectiveness clinical study were followed for 36
months (3 years) after surgery in the first phase of the study and up to 60 months (5years) or longer in the second phase of the study. The safety follow-up of study
patients included the following events:•

Additional surgeries;•

Cataract formation;•

Loss of best corrected vision with eyeglasses (BCVA)•

Raised pressure inside the eye (intraocular pressure) and damage to the optic
nerve caused by increased pressure in the eye (glaucoma);•

Loss of cells on the innermost surface of the cornea (endothelial cells);•

Other complications.

31

Detailed information regarding the adverse events observed in the Visian ICL ClinicalStudy can be found in Section 6 – Benefits and Risks.

Visian ICL for Myopia Adverse Event Patient Survey Study
A survey study was conducted in the US after Visian ICL for Myopia was approved by
the FDA. The goal of this study was to collect safety information from patients who had
ICL surgery in the general population. All patients who consented to participate wereasked to complete surveys at scheduled times up to 5 years after their Visian MICL
surgery. The surveys asked patients to report any complications or additional eye
surgeries because of the MICL.
Description of the Study Patient Group:• 2999 eyes of 1547 patients implanted with the Visian MICL participated;•

Most patients were white (Caucasian) and over half of the patients werefemale;•Patients ranged from 17 to 77 years of age at time of surgery.

The surveys asked for information about the following adverse events:• Problems with cells on the innermost surface of the cornea (endothelial cells);•

Cataract formation;•

Medical treatment for inflammation inside the eye;•Medical treatment for raised pressure inside the eye (intraocular pressure)and damage to the optic nerve caused by increased pressure in the eye(glaucoma);•

Surgery because of separation of the layer of nerve tissue at the back of theeye (retinal detachment) that captures images;•

Surgery to remove, replace or reposition the Visian ICL;•Other complications in the eye.

Overall, patient responses to surveys provided similar information to what was found in
the FDA safety and effectiveness clinical study of 526 eyes of 294 patients. This study
included patients over 45 years of age. This age group was not included in the FDA
32

safety and effectiveness study of the Visian ICL. These older patients reported a higher
rate of cataracts and need for a second surgery than patients who were 45 or younger at
the time of initial Visian ICL surgery.

Detailed information regarding the adverse events observed in the Visian ICL for Myopia
Adverse Event Patient Survey Study can be found in Section 6 – Benefits and Risks.

15.0 Summary of Important Information•

Visian ICL Surgery provides a permanent correction of your nearsightedness as long as
the Visian ICL remains in the eye. The Visian ICL may be removed. If your physician
removes the Visian ICL, you will lose the benefit of your nearsightedness correction. Thismeans that your vision may not return to what it was like before the Visian ICL surgery.

•

Visian ICL surgery does not eliminate the need for reading glasses, even if you havenever worn them before.

•

Your vision must be stable before Visian ICL surgery. You must provide written
evidence that your nearsightedness has changed no more than 0.50 D each year for atleast 1 year.

•

Pregnant and nursing women should wait until they are not pregnant and not nursing tohave the Visian ICL surgery.

•

Visian ICL surgery has some risks. Please read and understand this entire booklet before
you agree to the surgery. The sections on Risks (Section 6.0), Warnings (Section 8.0)
and Precautions (Section 9.0) are especially important to read carefully.

•

Some other options to correct nearsightedness include glasses, contact lenses, RK, PRK
and LASIK.
33

•

Before considering Visian ICL surgery you should:

a. have a complete eye examination.
b. talk with at least one eye care professional about Visian ICL surgery, especiallythe potential benefits, risks, and complications. You should discuss the timeneeded for healing after surgery.
•

Certain eye diseases, eye conditions, previous eye surgery, systemic medical conditions
may have an impact on the results after Visian ICL surgery. It is important that you
provide your doctor with your complete medical history so your doctor may determine if
you are a good candidate for the Visian ICL for correction of nearsightedness..

•

The Visian ICL is intended to improve your vision. However, because you arenearsighted, you should consult with your eye doctor on a regular basis (i.e., once a year)
to verify the overall health of your eye.

Answers to Self-Test Questions:
1. F
2. F
3. F
4. T
5. T

6. F
7. F
8. F
9. T
10. F

34

16.0 Patient Assistance Information
To be completed by you or your Primary Eye Care Professional as a reference.

Primary Eye Care Professional
Name:
Address:
Phone:
Visian ICL Doctor
Name:
Address:
Phone:
Treatment Location
Name:
Address:
Phone:

Visian ICL Manufacturer and Distributor:

STAAR Surgical Company
1911 Walker Avenue
Monrovia, CA 91016 USA

Tel: (800) 352-7842
FAX: (800) 952-4923

MKT-0125 Rev 335