Visian® Toric ICL ™ (Implantable Collamer® Lens)
For Nearsightedness with Astigmatism
Facts You Need To Know About STAAR Surgical’s Visian Toric ICL
SURGERY
PATIENT INFORMATION BOOKLET
For Nearsightedness (Myopia) between –3.0 to –20.0 Diopters with Astigmatism
between 1.0 to 4.0 Diopters

Please read this entire booklet. Discuss its contents with your doctor so that you
have all 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 2017 by STAAR Surgical Company

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

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CAUTION: U.S. (Federal) law restricts this device to sale by or on theorder of a physician.

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TABLE OF CONTENTS

1.0 Glossary ........................................................................................................................ 4
2.0 Introduction ................................................................................................................... 9
3.0 What Is Nearsightedness with Astigmatism ................................................................. 9
4.0 Other Treatments to Correct Nearsightedness with Astigmatism............................... 13
5.0 Benefits and Risks of Visian Toric ICL for Nearsightedness with Astigmatism ...... 14
6.0 Contraindications ........................................................................................................ 23
7.0 Warnings ..................................................................................................................... 23
8.0 Precautions .................................................................................................................. 26
9.0 Are You a Good Candidate for Visian Toric ICL Surgery? ....................................... 27
10.0 What Should You Expect During Visian Toric ICL Surgery? ................................. 28
11.0 Questions To Ask Your Doctor ................................................................................ 31
12.0 Self-Test .................................................................................................................... 32
13.0 Clinical Studiesof ...................................................................................................... 33
14.0 Summary of Important Information .......................................................................... 38
15.0 Patient Assistance Information ................................................................................. 40

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1.0 GLOSSARY
This section summarizes important terms used in this information booklet or that youreye doctor may discuss with you. Please discuss any related questions with your doctor.

Acute: Of sudden, rapid onset, usually with notable symptoms.
Acute Corneal Decompensation: A sudden swelling of the usually clear front surfaceof the eye (cornea).
Anisocoria: Unequal pupil size.
Anterior Chamber: Front chamber of the eye; anterior chamber depth is the space
between the back 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 Toric 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 the medication after Visian Toric ICL surgery.
Astigmatism: A focusing error that results in blurred distant and/or near vision. The
cornea is more 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 otherconnective tissue of the body.
Collamer: Hydroxyethyl methacrylate (HEMA)/porcine-collagen based polymer
material (STAAR proprietary product).
Conjunctival Irritation: A reddening of the observable, white portion of the eyeballand inner eyelid.
Contraindications: Any special conditions that result in the treatment not being
recommended.
Cornea: The clear front layer of the eye. Surgery such as PRK, LASIK and RK
reshapes the front surface of the cornea to improve distant vision.

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Corneal Edema: Abnormal fluid build-up/swelling in the cornea. The condition isusually temporary after surgery with no significant effect on vision. Persistent corneal
swelling may cause a loss of vision.
Corneal Endothelium: A thin, single layer of cells on the innermost surface of thecornea, responsible for keeping the cornea clear. These cells do not reproduce anddecrease in number with age.
Corneal Flap: A thin slice of tissue on the surface of the cornea made with amicrokeratome 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 the cornea.
Crystalline Lens: A structure inside the eye that helps to focus light onto the backsurface (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 eyes 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
surface of the cornea keeps the cornea clear by pumping water out of it. Normally, thesecells slowly decrease in number as you age. Additional loss of these cells beyond thenormal amount can occur 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 otherlighted object. This symptom may occur after surgery.
Hyphema: Blood in the front (anterior) chamber of the eye.
5Hypopyon: Discharge in the front (anterior) 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 tocorrect or reduce nearsightedness. The Visian ICL can be replaced or removed.
Implantable Toric Collamer Lens (TICL): A lens made of collagen containing
polymer which is implanted in the eye behind the iris and in front of the crystalline lensin order to correct or reduce nearsightedness and astigmatism. The Visian Toric ICL canbe replaced or removed
Inflammation of the Eye: The eye’s response to injury, infection or irritation which cancause 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 such as 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 or other portion of the eye.
Laser Assisted In-Situ Keratomileusis (LASIK): A type of eye surgery that uses a
device to create 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 thetissue heals.
Lens: Natural crystalline lens in the eye which helps focus light properly into the back of
the eye.
Macular Degeneration: A reduction in your central vision due to the thinning of a partof your retina responsible for fine (reading) vision.
Macular Edema: Swelling in the area responsible for fine (reading) vision on the backsurface of the eye (retina).
Macular Hemorrhage: Bleeding in the area responsible for fine (reading) vision on theback surface of the eye (retina).
Myopia: A focusing error that results in blurrier vision at distance than near. Myopia isalso called nearsightedness.

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Narrow Anterior Chamber Angle: A decrease in the size of the front chamber of theeye which could block the flow of fluid from inside to outside of the eye resulting in araised eye pressure (glaucoma).
Nearsighted/Nearsightedness: A focusing error that results in blurrier vision at distancethan near. Nearsightedness is also called myopia.
Non-reactive Pupil: A condition where the pupil of the eye does not get larger orsmaller when light is shined in the eye or removed.
Ocular Hypertension: Increased eye pressure.
Peripheral Anterior Synechiae: Scar tissue at the outer edges of the front chamber ofthe eye.
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 theend of the study.
Phakic Intraocular Lens: A thin man-made lens that is placed in an eye that still has its
natural crystalline lens.
Photorefractive Keratectomy (PRK): A type of eye surgery that uses a laser to reshape
the front 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. Afterthe surgery, the epithelium grows back.
Pigment Dispersion: An abnormal release of pigment particles from cells in the eye that
could block 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 opening in the middle of the colored portion (iris) of the eye; fluctuates insize allowing varying degrees of light into the eye.
Pupillary Block Glaucoma: The inability of fluid to flow from the back chamber of theeye to the 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 of the eye by making a special pattern of cuts in the cornea to correctnearsightedness and/or astigmatism.

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Retina: The layer of nerve tissue at the back of the eye that captures images, similar tofilm in a camera, and sends information about these images to the brain. Light must be
focused correctly on the retina to form clear images.
Retinal Detachment: Separation of the retina from its natural position on the backsurface of the eyeball.
Subretinal Hemorrhage: Bleeding under the retina.
Uveitis: Inflammation of the middle layer of tissue in the eye.
Viscoelastic Fluid: Gel-like fluid placed inside the eye during eye surgery to help
maintain the shape of the eye
Visian ICL for Myopia (MICL): Implantable Collamer Lens for the correction ofnearsightedness. This lens is similar in design to the Visian Toric ICL except that it does
not correct astigmatism.
Visian Toric ICL (TICL): Implantable Collamer Lens for the correction ofnearsightedness with astigmatism.
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 best vision without eyeglasses or contact lenses.
Vitreous Loss: The loss of a clear gel like material from the farthest back chamber ofthe eye during a surgical procedure.
YAG Laser: Yttrium Aluminum Garnet laser beam used in ophthalmology to create asmall 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 Toric
Implantable Collamer Lens (TICL) placed in one or both of your eyes to treat yournearsightedness (or myopia) and astigmatism. It is important for you to understand boththe benefits and risks of this surgery before you make a decision. The “Glossary” in thisbooklet explains the meaning of all words printed in italics. Please read this entire
booklet carefully and discuss your questions with a doctor who is trained in Visian Toric
ICL surgery.

3.0 What Is Nearsightedness with Astigmatism
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 eye with 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.

9You may have nearsightedness with astigmatism if you have trouble seeing objects
clearly when they are far away.

Nearsightedness, which is also called myopia, is a focusing error that causes blurrier
vision at distance than at near. Light from an object in the distance focuses in front of theback surface of your eye (retina) responsible for capturing images, rather than directly on
the retina. Diagram 2 shows how a nearsighted eye with blurry vision focuses light at apoint in front of the retina.

DIAGRAM 2: NEARSIGHTED EYELight focuses in front of the retina.
Vision is blurry.

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Astigmatism can cause similar symptoms. In eyes with astigmatism, the clear front layerof the eye that 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 other parts. Diagram 3 shows how an eye with nearsightedness
and astigmatism may focus light.

DIAGRAM 3: NEARSIGHTED and ASTIGMATIC EYEYour eyeglass prescription tells your doctor how nearsighted you are and how muchastigmatism your eyes have. Glasses, contact lenses or eye surgery can help your eye
focus light properly on the retina. This will correct nearsightedness and astigmatism andhelp you see distant objects more clearly. The Visian Toric ICL can also help your eye
focus light properly on the retina.

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How Does Visian Toric ICL Correct Nearsightedness With Astigmatism?
The Visian Toric ICL is 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) tocorrect vision after cataract surgery. The Visian Toric ICL is placed in the eye through asmall cut, and is placed behind the colored part of the eye (iris) and in front of the naturallens (crystalline lens). When placed correctly, the Visian Toric ICL focuses lightproperly on the back surface of your eye (retina). Diagram 4 shows how light is focusedin a nearsighted eye with astigmatism that has been implanted with a Visian Toric ICL.

DIAGRAM 4: CORRECTION OF VISION AFTER VISIAN TORIC ICLSURGERY
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. Your eyeglass prescription is the usual way totell how nearsighted you are and how much astigmatism you have. Visian Toric ICL
surgery is designed to treat nearsightedness between –3.0D to –15.0D, and astigmatism
between 1.0 and 4.0D. Visian Toric ICL surgery is designed to reduce nearsightedness
greater than –15.0D up to –20.0D, and astigmatism between 1.0D and 4.0D. If you havenearsightedness with astigmatism within these ranges, Visian Toric ICL surgery may
improve your distance vision without eyeglasses or contact lenses.
Your doctor will use your eyeglass prescription with a thorough eye examination todetermine if you are a candidate for Visian Toric ICL surgery. Discuss with your doctor
whether you are a good candidate for surgery with the Visian Toric ICL.
Visian Toric ICL surgery is permanent as long as the lens stays in your eye. The Visian
Toric ICL can be removed at a future date. However, the residual effect of the Visian
Toric ICL on your eye after it is removed is not known. If your physician removes the
Visian Toric ICL, you will lose the benefit of your nearsightedness with astigmatism
correction. This means that your vision may not return to what it was like before the
Visian Toric ICL surgery.

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

5.0 Benefits and Risks of Visian Toric ICL for Nearsightedness with Astigmatism
Benefits
Visian Toric ICL surgery can safely correct nearsightedness between –3D to –15D with
between 1.0D to 4.0D of astigmatism, and can partially correct nearsightedness in eyeswith greater than -15D up to -20D of myopia and between 1.0 to 4.0D of astigmatism.
If your eyeglass prescription is in these ranges, the Visian Toric ICL may make yourdistance vision without eyeglasses or contact lens correction better. Placing the Visian
Toric ICL into the eye requires surgery, and all eye surgery carries potentially serious
risks. Please review this booklet and discuss the risks with your doctor.

Risks
This part of the booklet explains the risks of Visian Toric ICL surgery. The Toric ICL is a
modification of an earlier model of ICL, which corrected nearsightedness (myopia) but
not astigmatism. The risks associated with this earlier ICL model all apply to the Toric
ICL as well. Information concerning risks was collected in the following clinical studies
for the FDA:
1. FDA Safety and Effectiveness Study of the Visian Toric ICL (TICL)This study collected information on the benefits and risks of the TICL. The study
followed 210 eyes of 124 patients through 12 months (1 year) after surgery.

2. FDA Safety and Effectiveness Study of the Visian ICL
In an earlier study for the Visian ICL for Myopia (MICL), 526 eyes of 294 patientswere followed through 36 months (3 years) after surgery; a smaller set of thesepatients (335 eyes of 192 patients) were followed through approximately 5 years(or longer) after surgery. The study doctors collected information on the items
listed below:•

Additional surgeries;
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•

Cataract formation:•

Loss of best corrected vision (BCVA)•

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

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

Other complications.

3. Patient Survey Study for the Visian ICL
A patient survey study for the Visian ICL for Myopia collected information on
adverse events and complications reported by 1547 patients (2999 eyes) up to 5
years after surgery (2125 eyes)

Please see section 13.0 Clinical Studies, for more information about these FDA studies.
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 Toric ICL may benecessary. You may also need another surgery if you develop a cataract or to lower
increased pressure inside your eye.
FDA Safety and Effectiveness study for the Visian Toric ICL (TICL)•

8 out of 210 eyes (3.8%) implanted with a Visian Toric ICL needed anothersurgery:o one eye (0.5%) had a second surgery to change the position of the lens,o one eye (0.5%) had a second surgery to replace the a Visian Toric ICL,o 3 eyes (1.4%) had a second surgery to remove the Visian Toric ICL,o 3 eyes (1.4%) needed another surgery to treat or prevent raised pressure
inside the eye (intraocular pressure or IOP):

2 eyes (1.0%) had another hole placed in the extreme outer edge ofthe colored portion of the eye (peripheral iridotomy) to prevent anincrease in eye pressure,15



one eye (0.5%) needed another surgery to remove the remaining
gel-like fluid used during eye surgery (viscoelastic fluid) thatcaused an increase in pressure inside the eye.

FDA Safety and Effectiveness Study of the Visian ICL for Myopia•

43 out of 526 implanted eyes (8.2%) had another surgery related to the Visian ICL
through 5 to 7 years after implantation:o 4 eyes (0.8%) had a second surgery to change the position of the VisianICL,
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 associatedwith cataract surgery.

•20 out of 526 implanted eyes (3.8%) had a second surgery to treat raised pressure
inside the eye:o 17 eyes (3.2%) had another hole placed in the extreme outer edge of thecolored 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
used during eye surgery (viscoelastic fluid).

Patient Survey Study for the Visian ICL•

126 out of 2999 implanted eyes (4.2%) had another surgery to reposition, replaceor remove the MICL through 5 years after implantation.

Cataract Formation
A cataract is a clouding of the natural lens inside the eye that can decrease vision.
Because the Visian Toric ICL is placed inside the eye near the natural lens, there is a riskof developing a cataract that may need surgery. Older age and higher levels ofnearsightedness before surgery also increase the risk for cataract after surgery with16

Visian Toric ICL. The risk of a cataract continues to rise with each year that the Visian
Toric ICL is in the eye. Because of this, you should see your doctor regularly for an eye
exam to check you for cataracts.
Cataracts that affect vision may require surgery to remove the cataract.
FDA Safety and Effectiveness study for the Visian Toric ICL (TICL)•

6 eyes (2.9%) developed some form of cataract by 12 months after surgery.

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
some form of cataract.

Patient Survey Study for the Visian ICL•

154 out 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 Toric ICL and the cataract is removed and anotherintraocular lens is implanted, just as is done in any routine cataract surgery.

Loss of best corrected vision (BCVA)FDA Safety and Effectiveness study for the Visian Toric ICL (TICL)•

three eyes (1.4%) in the FDA study of the Visian Toric ICL lost two or more linesof vision:o one eye (0.5%) lost vision due to clouding of the natural lens (cataract),o one eye (0.5%) lost vision without a reason given. This vision loss was notdue to cataract and the patient reported being very satisfied with her
vision.
o one eye (0.5%) lost two lines of vision compared to before surgery at 6
months and 12 months after surgery but vision improved by one line at 17
months after surgery.

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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 asmeasured 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 befrom 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) andcause permanent vision loss. Patients with high levels of nearsightedness are also at
increased risk of developing glaucoma.
FDA Safety and Effectiveness study for the Visian Toric ICL (TICL)•

2 eyes (1.0%) had an increase in IOP to values greater than 10mmHg higher than
before Vision Toric ICL surgery,•one eye (0.5%) had an increase in IOP to higher than 25mmHg at 6 months after
surgery, which dropped to 17mmHg at 12 months,•

one eye (0.5%) experienced raised IOP due to the inability of fluid to flow fromthe back chamber of the eye to the front chamber (pupillary block glaucoma). The
patient received another surgery (Peripheral Iridotomy) which resolved the
problem.
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No patients in the Visian Toric ICL study developed damage to the optic nerve(glaucoma).

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 thecolored 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
used during 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 or more years after ICL surgery. The first case of glaucoma wasdiagnosed 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 of the 2999 implanted eyes (1.6%) had 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 theinside of your eye, keeps the cornea clear by pumping water out of it. Normally, thesecells slowly decrease in number as you age. Additional loss of these cells beyond thenormal amount can happen after many kinds of eye surgery. If too many cells are lost, thecornea can become cloudy, which can decrease vision.
Loss of endothelial cells can happen after Visian Toric ICL surgery. Before your surgery,you will have an eye exam that will help your doctor decide if you are a candidate for
Visian Toric ICL surgery. Patients implanted with the Visian Toric ICL experience some19

loss of endothelial cells and a continuing loss of endothelial cells over time that is greaterthan that expected from aging.

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 beencaused by the surgical 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 yourcornea be removed and replaced (corneal transplantation).
Glare and Halos
Glare and halos are common in patients with astigmatism even if they never had any
ocular surgery. They may be more bothersome in low light conditions when the pupil isdilated. Even if patients don’t have glare and halos before Visian Toric ICL surgery, they
may develop glare and halos after surgery. If you currently experience glare and halos,
there is a chance that they may be more severe after Visian Toric ICL surgery.

FDA Safety and Effectiveness study for the Visian Toric ICL (TICL)
Glare•

29 out of 210 eyes (13.8%) of patients reported glare before surgery. At 1 year
after surgery, 37 out of 185 eyes (20%) of patients reported glare.

20•

28 of 185 eyes (15.1%) of patients noted increased glare symptoms at 1 year
after surgery compared to before surgery.

Halos
•

28 of 210 eyes (13.3%) of patients reported halos before surgery. At 1 year after
surgery, 37 out of 185 eyes (20%) of patients reported halos.

•

33 of 185 eyes (17.8 %) of patients noted increased halos at 1 year after surgery
compared to before 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.

•

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
many of the patients that 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 Toric ICL surgery may include:21•

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 (macularhemorrhage),•

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

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

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 thepressure in the eye (pupillary block glaucoma),•

unequal pupil size (anisocoria).

Potential complications are not limited to those reported during the clinical studies. 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
decompensation) after surgery that does not cause a loss of vision,•

continuing abnormal fluid build-up/swelling in the cornea (persistent corneal
edema) 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 oflight that may appear around a headlight or other lighted object (halos),•blood in the eye (hyphema),•discharge in the eye (hypopyon),•

Visian Toric ICL dislocation,•

cyst-like swelling 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 whenlight is shined in the eye (non-reactive pupil),22•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).

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

7.0 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 Toric ICL.

•

The long-term effects of the Visian Toric ICL on the thin, single layer of cells on
the surface of the 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 for Myopia (for nearsightedness), some patients had 30% or greaterloss of corneal endothelial cells. You should be aware that a greater than normalbuild-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 to23check your endothelium as long as you have the Visian Toric ICL in your eye(s).
This will help your doctor monitor the long-term health of your cornea.
•

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

•

When the Visian Toric ICL is placed in the eye, there is an increased risk of anearly increase in pressure inside your eye (intraocular pressure or IOP). This is
usually caused by blockage of fluid flow in the eye that requires treatment with asecond surgery. The long-term risks of the following types of complications are
not well established:

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 the drainage 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 insideof the eye. After Visian TICL surgery, this drainage area may get more narrowand should be monitored by your doctor. It is important that you return to thedoctor after surgery, according to the schedule that he provides.

•

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

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

25

8.0 Precautions
1. Patients with higher amounts of nearsightedness with astigmatism had worse
results. The Visian Toric ICL was less effective in correcting nearsightedness andthere was a higher risk of complications in these patients.
2. The relationship between the Visian Toric ICL and lifting or pulling of the retina
from its natural position (retinal detachment) is not known.
3. 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 by sun gazing or reduction in your central vision due to thethinning of a part of your retina (macular degeneration).
4. The safety of and ability of the Visian Toric ICL to correct moderate to highnearsightedness with astigmatism has NOT been established in patients with:

unstable or worsening nearsightedness with astigmatism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);history of previous eye surgery such as removal and replacement of thecornea (corneal transplant) or surgery to repair the layer of the nerve tissue atthe back of the eye that captures images (retina) after it has separated from its
natural position on the back surface of the eyeball (retinal detachment);life-threatening non-ocular disease (e.g., end-stage heart failure or kidneydisease);

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);26



abnormal release of pigment inside the eye (pigment dispersion);

greater than -20D or lower than -3.0D of nearsightedness; greater than 4.0D
or lower than 1.0D of astigmatism.

9.0 Are You a Good Candidate for Visian Toric ICL Surgery?
Your doctor will conduct a thorough eye examination to determine if you are a candidate
for Visian Toric ICL surgery. In addition, if you are considering Visian Toric ICL surgery
for nearsightedness with astigmatism you must:•

be between the ages of 21 and 45;•

have between –3D and –20D of nearsightedness and between 1.0D and 4.0D of
astigmatism•

understand that the Visian Toric ICL is indicated for the correction ofnearsightedness with astigmatism between –3D and ≤ -15D and between 1.0D
and 4.0D of astigmatism , and the reduction of nearsightedness with astigmatism
between > -15D and –20D and between 1.0D and 4.0D of astigmatism;•

have the shape of your eye able to fit the Visian Toric ICL (have an anteriorchamber 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 your doctor determines that your endothelial cell density is below theminimum 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 surgery with Visian Toric ICL fornearsightedness with astigmatism compared to other available treatments fornearsightedness with astigmatism;27

•

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 at between 2 to 3 weeks before Visian Toric ICL surgery you willneed to have holes made in the extreme outer edge of the colored portion of theeye (peripheral iridotomy) using a laser;•

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

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

10.0 What Should You Expect During Visian Toric ICL Surgery?
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 arehealthy and if you are a good candidate for Visian Toric ICL surgery. This examination
will include a measurement of the inner 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 eyemeasurement. 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 yourdoctor if you should eat or drink right before the surgery. You should also arrange fortransportation since you must not drive immediately after surgery. Your doctor will
let you know when your vision is good enough to drive again.

28

Two to Three Weeks before Surgery
Two to three weeks before your Visian Toric ICL surgery, your doctor will make twoholes in the extreme outer edge of the colored portion of the eye (peripheral iridotomies)
to prepare your eye for implantation of the Visian Toric ICL. This is necessary to makesure 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 Toric ICL surgery. The
doctor will usually apply numbing drops to the eye and make tiny openings in the colored
portion of the eye (iris) with a laser beam. Usually this doesn't affect your ability to drive
home after this procedure, but check with your doctor.
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 blackpart of your eye (pupil).
Once your pupil is fully dilated, your doctor will put numbing eye drops in your eye
and/or inject a needle with numbing medication into your eye and ask you to lie on yourback on the treatment table/chair in the treatment room. Your doctor may discussalternative 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 Toric ICL is inserted and positioned in its proper position in the eye as
illustrated in Diagram 4 at the beginning of this booklet. The entire procedure willusually take approximately 20 to 30 minutes or less.
After the surgery is complete, your doctor will place some eye drops/ointment in youreye. For your eye protection and comfort, your doctor may apply a patch or shield overyour eye. The procedure is painless because of the numbing medication. It is important29

that you do not drive yourself home and make arrangements before the day ofsurgery for transportation home.

The First Days after Surgery
Your physician will need to see you the day after surgery for a checkup 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 canprescribe 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 Toric ICL repositioning,
replacement and/or removal may become necessary. Visian Toric ICL repositioning may
be performed if your doctor finds the Visian Toric ICL is not properly aligned in the
direction of astigmatism. Visian Toric ICL replacement may be performed if your doctor
believes a different lens may either fit your eye better or provide you better vision.
Visian Toric ICL removal may be necessary if you develop a cataract and your doctor
recommends surgery. If you need to have cataract surgery, the intraocular lens used toreplace your natural crystalline lens can often correct your nearsightedness withastigmatism. If your doctor removes the Visian Toric ICL, you will lose the benefit ofyour nearsightedness with astigmatism correction. This means that your vision may not30return to what it was like before the Visian Toric ICL surgery. After Visian Toric ICL
surgery it is important that you follow your physician’s recommendations for eye careand follow-up visits.

11.0 Questions To Ask Your Doctor
You may want to ask the following questions to help you decide if Visian Toric ICL
surgery for nearsightedness with astigmatism is right for you:•

What are my other options to correct my nearsightedness with astigmatism?

•

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

•

What are the benefits of Visian Toric ICL surgery for my amount of nearsightedness
with astigmatism?

•

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

•

If Visian Toric 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 the correctionof my vision?

•

How is Visian Toric ICL surgery likely to affect my need to wear eyeglasses orcontact lenses as I get older?

•

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

•

Should I have Visian Toric 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 a Visian Toric ICL only in one
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 withastigmatism.

3112.0 SELF-TESTAre 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 Toric ICL surgery for nearsightedness withastigmatism is the same as laser surgery.

□

□

2.

Visian Toric ICL surgery is risk-free.

□

□

3.

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

□

□

4.

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

□

□

5.

There is a risk I may lose some best corrected vision after
Visian Toric 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
chamber of the eye (narrow anterior chamber angles) which
could block the flow of fluid from the inside to the outside ofthe eye, I am still a good candidate for Visian Toric ICL
surgery.

□□

8.

The Visian Toric ICL will correct my astigmatism and mynearsightedness.

□

□

9.

It is important I follow my eye 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.

32

13.0 Clinical Studiesof
Safety and Effectiveness FDA Study of the Visian Toric ICL for Nearsightedness
with Astigmatism (TICL)
A clinical study was conducted to evaluate the benefits and risks of Visian Toric ICL
surgery.
Description of the Study Patient Group:•

210 eyes of 124 patients were implanted with a Visian Toric ICL•

Most patients were white (Caucasian) and over half of the patients werefemale•Patients ranged from 21 to 45 years of age at time of surgery•

Nearsightedness before surgery ranged between –2.38D and –19.5D. The
average was –9.37D.

•

Astigmatism before surgery ranged between 1.0D and 4.0D. The average was
1.95D

The clinical study was conducted to study the following:•

Visual Acuity without glasses after surgery•

Ability to the Visian Toric ICL to correct nearsightedness andastigmatism•

Patient satisfaction after Visian Toric ICL Surgery•

Quality of Vision after Visian Toric ICL Surgery

Visual Acuity Without Glasses after Surgery:•

Visual acuity measures the sharpness of vision using a letter chart. In the
United States, a visual acuity of 20/40 or better measured on an eye chart isrequired in most states to drive a car without glasses or contact lenses. One
year after insertion of the Visian ICL, 100% of eyes in the Visian Toric ICL
study saw 20/40 or better without glasses or contact lenses.

•

Table 1 shows the percent of patients in the study that had 20/20 or better and20/40 or better vision without glasses, measured using an eye chart. The table33

shows vision at time points after surgery, either for all patients (All Study
Patients row) or based on their degree of nearsightedness before Visian Toric
ICL surgery.
Table 1: Visual Acuity* Without Glasses, After Surgery by Range of Nearsightedness(Myopia) Before Surgery
Lens GroupAll Study Patients≤ -7D of myopia

Exam Interval

20/20 or Better

20/40 or Better

1 Week

76.6%

99.4%

1 Month

83.7%

98.8%

3 Months

87.0%

100%

6 Months

90.3%

100%

12 Months

89.3%

100%

12 Months

93.9%

97.0%

12 Months

83.9%

97.8%

12 Months

77.0%

96.7%

12 Months

33.3%

33.3%

before surgery> -7D to -10D
myopia before
surgery> -10D to -15D
myopia before
surgery> -15D myopia
before surgery*Eyes with range of nearsightedness (myopia) with glasses 20/20 or better before surgery and targeted
for complete correction

Patient Satisfaction after Visian Toric ICL Surgery:
Patients in the clinical study were asked to report their satisfaction with the Visian Toric
ICL procedure. One year (12 months) after Visian Toric ICL surgery, 97.8% of patientswere very/extremely satisfied and 2.2% were moderately/fairly satisfied with their vision.
No patients (0.0%) reported being unsatisfied.

Quality of Vision after Visian Toric ICL Surgery:34

Quality of vision reported by patients as very good/excellent improved from 64.3%
before the Visian Toric ICL to 94.6% at 12 months after the Visian Toric ICL procedure.
Patients reporting poor/very poor vision dropped to 0% at 12 months compared to 10.5%
before the Visian Toric ICL.
Patients in the clinical study were asked on a questionnaire to report on vision symptoms
before and 12 months after the Visian Toric ICL procedure. Responses are shown in
Table 2. Percentages of patients reporting Glare, Halos, Double Vision, Night Vision
and Night Driving Difficulties were similar before and after surgery.
Table 2: Vision Symptoms Reported by Patients
Improved
at 12
Months

No Change
at 12MonthsWorsened
at 12
MonthsHarsh or uncomfortable bright light(Glare)

10.3%

74.6%

15.1%

Circular flares/rings of light around lighted
objects (Halos)

11.4%

70.8%

17.8%

Seeing multiple images of the object being
looked at (Double Vision)

1.6%

96.8%

1.6%

Night Vision

12.5%

75.5%

11.9%

Night Driving Difficulties

11.0%

75.8%

13.2%

Symptom

The results of the FDA study showed that the Visian Toric ICL was able to correctnearsightedness with astigmatism in study patients. At 12 months after surgery,
89.1% of patients could read 20/20 without glasses and 95.3% could read 20/40
without glasses. At 12 months after surgery, 97.8% of patients reporting being“Very/Extremely Satisfied” with their vision and no patients reported being
unsatisfied.

Detailed information regarding the adverse events observed in the Visian Toric ICL
Clinical Study can be found in Section 5 – Benefits and Risks.

35

Safety and Effectiveness Study of the Visian ICL for Nearsightedness
A previous clinical study was conducted to evaluate the benefits and risks of Visian ICL
for Myopia (nearsightedness). The Visian ICL for Myopia (MICL) is similar to the Visian
Toric ICL except that it does not correct astigmatism. The Visian MICL study was
conducted in two phases: the first phase lasted three years after surgery to collecteffectiveness and safety information. The second phase involved collection of more
safety data to at least five years after Visian MICL surgery.
Description of the Study Patient Group:•

526 eyes of 294 patients were implanted with the Visian MICL•

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

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.

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 and some patientsstill needed glasses or contact lenses after surgery to view distant objects. At 3 years
after surgery, 94.7% of eyes saw 20/40 or better without glasses or contact lenses. A
total of 92.1% of patients reported being “Very/Extremely Satisfied” and only 2
patients reported being unsatisfied with their vision at 3 years after surgery.
36

Detailed information regarding the adverse events observed in the Visian ICL ClinicalStudy can be found in Section 5 – 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 ICL;•Other complications in the eye.

37

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
studies for TICL or MICL. These older patients reported a higher rate of cataract
formation or need for a second surgery than patients who were 45 or younger at the timeof initial MICL surgery.

Detailed information regarding the adverse events observed in the Visian ICL Adverse
Event Patient Survey Study can be found in Section 5 – Benefits and Risks.

14.0 Summary of Important Information•

Visian Toric ICL surgery provides a permanent correction of yournearsightedness with astigmatism as long as the Visian Toric ICL remains in theeye. The Visian Toric ICL may be removed. If your physician removes the Visian
Toric ICL, you will lose the benefit of your nearsightedness with astigmatism
correction. This means that your vision may not return to what it was like before
the Visian Toric ICL surgery.

•

Visian Toric ICL surgery does not eliminate the need for reading glasses, even if
you have never worn them before.

•

Your vision must be stable before Visian Toric ICL surgery. You must provide
written evidence that your nearsightedness with astigmatism has changed no morethan 0.50D each year for at least 1 year.

•

Pregnant and nursing women should wait until they are not pregnant and not
nursing to have Visian Toric ICL surgery.

•

Visian Toric ICL surgery has some risks. Please read and understand this entire
booklet before you agree to the surgery. The sections on Risks (Section 5.0)
Warnings (Section 7.0) and Precautions (Section 8.0) are especially importantto read carefully.
38•

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

•

Before considering Visian Toric ICL surgery you should:
a. have a complete eye examination,b. talk with at least one eye care professional about Visian Toric ICL surgery,especially the potential benefits, risks, and complications. You should
discuss the time needed for healing after surgery.

•

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

•

The Visian Toric ICL is intended to improve your vision. However, because you
are nearsighted, 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 6. F
2. F 7. F
3. F 8. F
4. T 9. T
5. T10. F

39

15.0 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 Toric ICL Doctor
Name:
Address:
Phone:
Treatment Location
Name:
Address:
Phone:

Visian Toric ICL Manufacturer and Distributor:
STAAR Surgical Company
1911 Walker Avenue
Monrovia, CA 91016 USA
Tel:(800) 352-7842
FAX:(800) 952-4923

MKT-0190 REV. 340