CooperVision Vertex Methafilcon A Soft Hydrophilic Contact Lenses Instruction Manual

Instruction Manual for CooperVision models including: Vertex, Vertex Toric, Methafilcon A Soft Hydrophilic Contact Lenses, Soft Hydrophilic Contact Lenses, Contact Lenses, Vertex, Lenses

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Vertex Vertex Toric Vertex Toric XR (methafilcon A) Soft (Hydrophilic) Contact Lenses CooperVision

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INSTRUCTIONS FOR WEARERS MANUAL
Contact Lenses for Frequent Replacement Daily and Extended Wear
Vertex Vertex Toric Vertex Toric XR (methafilcon A) Soft (Hydrophilic) Contact Lenses
CooperVision®
Table of Contents
INTRODUCTION........................................................................................................................... 2 WEARING RESTRICTIONS AND INDICATIONS..................................................................... 2 CONTRAINDICATIONS (REASONS NOT TO USE)................................................................. 2 WARNINGS ................................................................................................................................... 3 PRECAUTIONS FOR FREQUENT REPLACEMENT WEAR.................................................... 3 ADVERSE REACTIONS............................................................................................................... 5 PERSONAL CLEANLINESS FOR LENS HANDLING............................................................... 6
1. Preparing the Lens for Wearing: ...................... 6 2. Handling the Lenses: ................................. 6 3. Placing the Lens on the Eye: ......................... 6 4. Centering the Lens: .................................. 7 5. Removing the Lens: ................................... 7 CARING FOR YOUR LENSES (CLEANING, RINSING, DISINFECTING, ENZYMING, STORAGE, AND REWETTING/LUBRICATING) ................................... 8 1. Basic Instructions ................................... 8 2. Care for a Sticking (Nonmoving) Lens: ............... 10 3. Chemical Lens Disinfection (Including Hydrogen
Peroxide) ........................................... 11 4. Lens Deposits and Use of Enzymatic Cleaning ......... 11 5. Lens Case Cleaning and Maintenance .................. 11 6. Care for a Dried Out (Dehydrated) Lens: ............. 11 7. Emergencies ......................................... 12 INSTRUCTIONS FOR THE MONOVISION WEARER ............................................................ 12 PRESCRIBED WEARING SCHEDULE..................................................................................... 13 APPOINTMENT SCHEDULE..................................................................................................... 14
CAUTION: Federal Law Prohibits Dispensing Without a Prescription

Part Number: PIB01024 Revision A

Page 1 of 14 Revision Date: August 2016

INTRODUCTION

Your Vertex, Vertex Toric, or Vertex Toric XR contact lenses are made from a plastic material, methafilcon A, which has the ability to absorb water, making it soft and pliable. Whether your eye care practitioner prescribed your lenses for daily or extended wear, they are to be removed, discarded and replaced with a new sterile one on a Frequent Planned Replacement schedule determined by your eye care practitioner. To obtain maximum performance and satisfaction from your Vertex, Vertex Toric, or Vertex Toric XR lenses, the procedures, methods and wearing schedule must always be followed.

If you are in doubt about any instructions, request clarification from your eye care practitioner.

WEARING RESTRICTIONS AND INDICATIONS

1. Vertex lenses are indicated for daily wear or extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care practitioner. They are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

2. Vertex Toric and Vertex Toric XR lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care practitioner. They are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 12.00 diopters or less.

Your Vertex, Vertex Toric, or Vertex Toric XR lenses have been prescribed for frequent replacement wear and should be removed from your eyes and discarded as recommended by your eye care practitioner.

If prescribed for daily wear, DO NOT WEAR YOUR VERTEX, VERTEX TORIC, OR VERTEX TORIC XR LENSES WHILE SLEEPING.

Note: Only chemical disinfection may be used with Vertex, Vertex Toric, and Vertex Toric XR lenses.

CONTRAINDICATIONS (REASONS NOT TO USE)

DO NOT USE the Vertex, Vertex Toric, and Vertex Toric XR contact lenses when any of the following conditions exist:

Acute and subacute inflammation or infection of the anterior chamber of the eye.

Any eye disease, injury, or abnormality which affects the cornea, conjunctiva, or eyelids.

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Severe insufficiency of lacrimal secretion (dry eyes).

Corneal hypoesthesia (reduce corneal sensitivity), if not-aphakic.

Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.

Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by

wearing contact lenses or use of contact lens solutions.

Allergy to any ingredient, such as mercury or thimerosal, in a solution which is to be used to

care for Vertex, Vertex Toric, and Vertex Toric XR contact lenses.

Any active corneal infection (bacteria, fungal, or viral).

If eyes become red or irritated.

You are unable to follow lens care regimen or unable to obtain assistance to do so.

WARNINGS

You should be advised of the following warnings pertaining to contact lens wear:

Problems with contact lenses and lens care products could result in serious injury to

the eye. It is essential that you follow your eye care practitioner's directions and all

labeling instructions for proper use of lenses and lens care products, including the

lens case. Eye problems, including corneal ulcers, can develop rapidly and lead to

loss of vision.

Daily wear lenses are not indicated for overnight wear, you must not wear your

lenses while sleeping. Clinical studies have shown that the risk of serious adverse

reactions is increased when these lenses are worn overnight.

Studies have shown that contact lens wearers who are smokers have a higher

incidence of adverse reactions than nonsmokers.

If you experience eye discomfort, excessive tearing, vision changes or redness of the

eye, you should immediately remove your lenses and promptly contact your eye

care practitioner.

PRECAUTIONS FOR FREQUENT REPLACEMENT WEAR

Different solutions cannot always be used together, and not all solutions are safe for use with

all lenses. Use only the solutions recommended by your eye care practitioner.

Never use solutions recommended for conventional hard contact lenses only.

Use only chemical (not heat) disinfection with Vertex, Vertex Toric, and Vertex

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Toric XR lenses. Heat disinfection should not be used. Repeated heat disinfection will cause irreversible damage to Vertex, Vertex Toric, and Vertex Toric XR lenses.

Always use fresh unexpired lens care solutions.

Always follow directions in the package inserts for the use of contact lens solutions.

Sterile unpreserved solutions, when used, should be discarded after the time specified

in the labeling directions.

Do not use saliva or anything other than the recommended solutions for lubricating

or wetting lenses. Do not put the lenses in your mouth.

Always keep the lenses completely immersed in the recommended storage solution

when the lenses are not being worn (stored). Prolonged periods of drying may

damage the lenses. Follow the lens care directions for Care for a Dried Out

(Dehydrated) Lens if the lens surface does become dried out.

If the lens sticks (stops moving) on the eye, follow the recommended directions on Care for

a Sticking Lens. The lens should move freely on the eye for the continued health of the eye.

If nonmovement of the lens continues, you should immediately consult your eye care

practitioner.

Always wash and rinse your hands before handling the lenses. Do not get cosmetics, lotions,

soaps, creams, deodorants, or sprays in the eyes or on the lenses. It is best to put on lenses

before putting on makeup. Water-based cosmetics are less likely to damage lenses than oil-

based products.

Do not touch contact lenses with the fingers or hands if the hands are not free of foreign

materials, as lens damage may occur.

Carefully follow the handling, insertion, removal, cleaning, disinfecting, storing and

wearing instructions in this booklet and those prescribed by your eye care practitioner.

Never wear lenses beyond the period recommended by your eye care practitioner.

If aerosol products such as hair spray are used while wearing lenses, exercise caution and

keep eyes closed until the spray has settled.

Always handle lenses carefully and avoid dropping them.

Avoid all harmful or irritating vapors and fumes while wearing lenses.

Ask your eye care practitioner about wearing lenses during sporting activities.

Inform your doctor (health care practitioner) that you wear contact lenses.

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Never use tweezers or other tools to remove lenses from the lens container unless specifically

indicated for that use. Pour the lens into the hand.

Do not touch the lens with fingernails.

Always contact your eye care practitioner before using any medicine in the eyes.

Always inform your employer that you wear contact lenses. Some jobs may require use of

eye protection equipment or may require that you do not wear contact lenses.

As with any contact lens, follow-up visits are necessary to assure the continuing health of

your eyes. Your eye care practitioner will recommend a follow-up schedule.

ADVERSE REACTIONS

The following problems may occur:

Eyes stinging, burning, itching (irritation), or other eye pain

Comfort is less than when lens was first placed on eye

Feeling that something is in the eye such as a foreign body or scratched area

Excessive watering (tearing) of the eyes

Unusual eye secretions

Redness of the eyes

Reduced sharpness of vision (poor visual acuity)

Blurred vision, rainbows, or halos around objects

Sensitivity to light (photophobia)

Dry eyes

If you notice any of the above problems, you should:

Immediately remove your lenses.

If the discomfort or problem stops, then look closely at the lens. If the lens is in any way

damaged, do not put the lens back on your eye. Place the lens in the storage case and contact

your eye care practitioner. If the lens has dirt, an eyelash, or other foreign body on it, or the

problem stops and the lens appears undamaged, you should thoroughly clean, rinse and

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disinfect the lenses, then reinsert them. After reinsertion, if the problem continues, you should immediately remove the lenses and consult your eye care practitioner.
When any of the above problems occur, a serious condition such as infection, corneal ulcer, neovascularization, or iritis may be present. You should keep the lens off the eye and seek immediate professional identification of the problem and prompt treatment to avoid serious eye damage.
PERSONAL CLEANLINESS FOR LENS HANDLING

1. Preparing the Lens for Wearing:

It is essential that you learn and use good hygienic methods in the care and handling of your new lenses. Cleanliness is the first and most important aspect of proper contact lens care. In particular, your hands should be clean and free of any foreign substances when you handle your lenses.

The procedures are:

Always wash your hands thoroughly with a mild soap, rinse completely, and dry with

a lint-free towel before touching your lenses.

Avoid the use of soaps containing cold cream, lotion or oily cosmetics before

handling your lenses, since these substances may come into contact with the lenses

and interfere with successful wearing.

Handle your lenses with your fingertips and be careful to avoid contact with

fingernails. It is helpful to keep your fingernails short and smooth.

Start off correctly by getting into the habit of always using proper hygienic procedures so that they become automatic.

2. Handling the Lenses:

Develop the habit of always working with the same lens first to avoid mix-ups.

Remove the lens from its storage case and examine it to be sure that it is moist, clean,

clear, and free of any nicks or tears.

Rinse the lens thoroughly with fresh, sterile saline solution before placing it on your

eye.

3. Placing the Lens on the Eye:

Position the lens on the tip of the index finger of your dominant hand. With the

middle finger of the same hand, pull the lower eyelid down. Use the middle finger of

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the other hand to gently raise the upper eyelid by lifting the lid just above the eyelashes.

Look straight ahead and gently place the lens on your eye.

Slowly release the lids, close your eyes, and then open them slowly. The lens should

center automatically.

Repeat the procedure for the other eye.

There are other methods of lens placement. If the above method is difficult for you, your eye care practitioner will provide you with an alternate method.

Note: If after placement of the lens, your vision is blurred, check for the following:

The lens is not centered on the eye (see "Centering the Lens," next in this booklet).

If the lens is centered, remove the lens (see "Removing the Lens" section) and check

for the following:

a. Cosmetics or oils on the lens. Clean, rinse, disinfect, and place on the eye again.

b. The lens is on the wrong eye.

c. The lens is inside-out (it would also not be as comfortable as normal).

If you find that your vision is still blurred after checking the above possibilities, remove both lenses and consult your eye care practitioner.

4. Centering the Lens:

Very rarely, a lens that is on the cornea will be displaced onto the white part of the eye during lens wear. This can also occur during placement and removal of the lenses if the correct techniques are not performed properly. To center a lens follow one of the procedures below.

Close your eyelids and gently massage the lens into place through the closed lids

using your index finger.

b. Gently push the off-centered lens onto the cornea while the eye is open using finger pressure on the edge of the upper or lower eyelid.

5. Removing the Lens:

Always remove the same lens first. Wash, rinse, and dry your hands thoroughly. Have your lens storage case ready to put the lenses in upon removal.

Part Number: PIB01024 Revision A

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Always be sure that the lens is centered on the cornea before attempting to remove it.

Look straight ahead and up slightly. With the middle finger of your dominant hand,

pull the lower lid down slightly.

b. Gently pinch the lens between the index finger and thumb of your dominant hand.

Gently pull the lens away from the eye.

d. Repeat the procedure for the other lens.

Follow the required lens care procedures described under the heading, CARING FOR

YOUR LENSES (CLEANING, RINSING, DISINFECTING, ENZYMING,

STORAGE, AND REWETTING/LUBRICATING).

NOTE: If this method of removing your lenses is difficult for you, your eye care practitioner will provide you with an alternate method.

CARING FOR YOUR LENSES (CLEANING, RINSING, DISINFECTING, ENZYMING, STORAGE, AND REWETTING/LUBRICATING)

1. Basic Instructions

For continued safe and comfortable wearing of your lenses, it is important that you first clean and rinse, then disinfect and neutralize (for hydrogen peroxide systems) your lenses after each removal, using the care regimen recommended by your eye care practitioner. Cleaning and rinsing are necessary to remove mucus, secretions, films, or deposits which may have accumulated during wearing. The ideal time to clean your lenses is immediately after removing them. Disinfecting is necessary to destroy harmful germs.
You should adhere to a recommended care regimen. Failure to follow the regimen may result in development of serious ocular complications as discussed in the WARNINGS section above.
If you will not or cannot adhere to a recommended care regimen for your lenses, or are unable to place and remove lenses or have someone available to place and remove them, you should not attempt to get and wear contact lenses.
When you first get your lenses, be sure you are able to put the lenses on and remove them while you are in your eye care practitioner's office. At that time you will be provided with a recommended cleaning and disinfecting regimen and instructions and warnings for lens care, handling, cleaning, and disinfection. Your eye care practitioner should instruct you about appropriate and adequate procedures and products for your use, and provide you with a copy of the Patient Instructions for Vertex, Vertex Toric, and Vertex Toric XR contact lenses.

Part Number: PIB01024 Revision A

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For safe contact lens wear, you should know and always practice your lens care routine:

Always wash, rinse, and dry hands before handling the contact lenses.

Always use fresh, unexpired lens care solutions.

Use the recommended chemical (not heat) system of lens care and carefully follow

instructions on solution labeling. Different solutions cannot always be used together, and not

all solutions are safe for use with all lenses. Do not alternate or mix lens care systems

unless indicated on solution labeling.

Always remove, clean, rinse, enzyme, and disinfect your lenses according to the schedule

prescribed by your eye care practitioner. The use of an enzyme or any cleaning solution does

not substitute for disinfection.

Do not use saliva or anything other than the recommended solutions for lubricating or

rewetting your lenses. Do not put lenses in your mouth.

Never rinse your lenses in water from the tap. There are two reasons for this:

Tap water contains many impurities that can contaminate or damage your lenses and

may lead to eye infection or injury.

b. You might lose a lens down the drain.

Your eye care practitioner should recommend a care system that is appropriate for your

Vertex, Vertex Toric, or Vertex Toric XR contact lenses. Each lens care product contains

specific directions for use and important safety information, which you should read and

carefully follow.

Lens Care Table

Product Purpose To: Clean Rinse Disinfect Store

Chemical (Not Heat) Lens Care System
ReNu® Multi-Purpose Solution MiraFlow® Extra-Strength Daily Cleaner Opti-Free® Daily Cleaner
ReNu® Multi-Purpose Solution SoftWear® Saline Opti-Free® Rinsing, Disinfecting, and Storage Solution
ReNu® Multi-Purpose Solution AOSEPT® Disinfection/Neutralization Solution Opti-Free® Rinsing, Disinfecting, and Storage Solution
ReNu® Multi-Purpose Solution Opti-Free® Rinsing, Disinfecting and Storage Solution

Part Number: PIB01024 Revision A

Page 9 of 14 Revision Date: August 2016

Product Purpose To: Lubricate/Rewet

Chemical (Not Heat) Lens Care System
ReNu® Rewetting Drops CIBA VisionTM Lens Drops Opti-Free® Rewetting Drops

Enzyme

ReNu® Effervescent Enzymatic Cleaner Tablets ULTRAZYME® Enzymatic Cleaner Opti-Free® Enzymatic Cleaner

Opti-Free® is a registered trademark of Alcon Laboratories, Inc. AOSEPT®, MiraFlow®, SoftWear® and CIBA VisionTM are registered trademarks of CIBA Vision Corporation. ReNu® is a registered trademark of Bausch & Lomb, Inc. ULTRAZYME® is a registered trademark of Allergan, Inc.

NOTE: Some solutions may have more than one function, which will be indicated on the

label. Read the label on the solution bottle, and follow the instructions.

Clean one lens first (always the same lens first to avoid mix-ups), rinse the lens thoroughly

with recommended saline or disinfecting solution to remove the cleaning solution, mucus,

and film from the lens surface. Follow the instructions provided in the cleaning solution

labeling. Put that lens into the correct chamber of the lens storage case. Then repeat the

procedure for the second lens.

After cleaning and rinsing, disinfect lenses using the system recommended by your eye care

practitioner and/or the lens manufacturer. Follow the instructions provided in the disinfection

solution labeling.

To store lenses, disinfect and leave then in the closed case until ready to wear. If lenses are

not to be used immediately following disinfection, you should consult the package insert or

your eye care practitioner for information on storage of your lenses.

After removing your lenses from the lens case, empty and rinse the lens storage case with

solution(s) recommended by the lens case manufacturer; then allow the lens case to air dry.

When the case is used again, refill it with fresh storage solution. Replace the lens case at

regular intervals.

Your eye care practitioner may recommend a lubricating/rewetting solution for your use.

Lubricating/Rewetting solutions can be used to wet (lubricate) your lenses while you are

wearing them to make them more comfortable.

2. Care for a Sticking (Nonmoving) Lens:

If the lens sticks (stops moving or cannot be removed), apply 2-3 drops of the recommended lubricating or rewetting solution directly to the eye and wait until the lens begins to move freely on the eye before removing it. If nonmovement of the lens continues more than 5-10 minutes, immediately consult the eye care practitioner.

Part Number: PIB01024 Revision A

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3. Chemical Lens Disinfection (Including Hydrogen Peroxide)

Clean your contact lenses with a recommended cleaning solution and thoroughly rinse them

with a recommended rinsing solution.

After cleaning and rinsing, to disinfect, carefully follow the instructions accompanying the

disinfecting solution in the care regimen recommended by your eye care practitioner or the

lens manufacturer.

When using hydrogen peroxide lens care systems, lenses must be neutralized before

wearing. Follow the recommendations on the hydrogen peroxide system labeling.

Thoroughly rinse your lenses with fresh rinsing solution before inserting and wearing, or

follow the instructions on the disinfection solution labeling.

Do not heat the disinfection solution and lenses.

Leave the lenses in the unopened storage case until ready to put on the eyes.

Caution: Lenses that are chemically disinfected may absorb ingredients from the

disinfecting solution which may be irritating to your eyes. A thorough rinse in fresh, sterile

saline solution prior to placement on your eye should reduce the potential for irritation.

4. Lens Deposits and Use of Enzymatic Cleaning

Enzyme cleaning may be recommended by your eye care practitioner. Enzyme cleaning removes protein deposits on the lens. These deposits cannot be removed with regular cleaners. Removing protein deposits is important for the well-being of your lenses and eyes. If these deposits are not removed, they can damage the lenses and cause irritation.

Enzyme cleaning does NOT replace routine cleaning and disinfecting. For enzyme cleaning, carefully follow the instructions in the enzymatic cleaning labeling.

5. Lens Case Cleaning and Maintenance

Contact lens cases can be a source of bacteria growth. Lens cases should be emptied, cleaned, rinsed with solutions recommended by the lens case manufacturer, and allowed to air dry. Lens cases should be replaced at regular intervals as recommended by the lens case manufacturer or your eye care practitioner.

6. Care for a Dried Out (Dehydrated) Lens:

If your Vertex, Vertex Toric, or Vertex Toric XR lens is exposed to air while off the eye, it may become dry and brittle and need to be rehydrated. If the lens is adhering to a surface, apply sterile saline solution before handling.

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To rehydrate the lens:

Handle the lens carefully.

Place the lens in its storage case and soak the lens in the recommended rinsing and storage

solution for at least one hour until it returns to a soft state.

Clean the lens first, then disinfect the rehydrated lens using a recommended lens care system.

If after soaking, the lens does not become soft, if the surface remains dry, do not use the lens

unless it has been examined by your eye care practitioner.

7. Emergencies

If chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are splashed into your eyes, FLUSH EYES IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONTACT THE EYE CARE PRACTITIONER OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY.

INSTRUCTIONS FOR THE MONOVISION WEARER

You should be aware that as with any type of lens correction, there are advantages and

compromises to monovision contact lens therapy. The benefit of clear near vision in straight

ahead and upward gaze that is available with monovision may be accompanied by a vision

compromise that may reduce your visual acuity and depth perception for distance and near

tasks. Some patients have experienced difficulty adapting to it. Symptoms, such as mild

blurred vision, dizziness, headaches, and a feeling of slight imbalance, may last for a brief

minute or for several weeks as adaptation takes place. The longer these symptoms persist, the

poorer your prognosis for successful adaptation. You should avoid visually demanding

situations during the initial adaptation period. It is recommended that you first wear these

contact lenses in familiar situations, which are not visually demanding. For example, it might

be better to be a passenger rather than a driver of an automobile during the first few days of

lens wear. It is recommended that you only drive with monovision correction if you pass your

state driver's license requirements with monovision correction.

Some monovision patients will never be fully comfortable functioning under low levels of

illumination, such as driving at night. If this happens, you may want to discuss with your eye

care practitioner having additional contact lenses prescribed so that both eyes are corrected

for distance when sharp distance binocular vision is required.

If you require very sharp near vision during prolonged close work, you may want to have

additional contact lenses prescribed so that both eyes are corrected for near when sharp near

binocular vision is required.

Some monovision patients require supplemental spectacles to wear over the monovision

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correction to provide the clearest vision for critical tasks. You should discuss this with your eye care practitioner.

It is important that you follow your eye care practitioner's suggestions for adaptation to

monovision contact lens therapy. You should discuss any concerns that you may have during

and after the adaptation period.

The decision to be fit with a monovision correction is most appropriately left to the eye

care practitioner in conjunction with you, after carefully considering and discussing

your needs.

Wearing and Appointment Schedules

Prescribed Wearing Schedule

DAY DATE
1 2 3 4 5 6 7 8 9 10 11 12 13 14

WEARING TIME (HOURS)

PRECAUTION: If prescribed by your eye care practitioner for daily wear, your Vertex, Vertex Toric, or Vertex Toric XR lenses should not be worn 24 hours a day.

Part Number: PIB01024 Revision A

Page 13 of 14 Revision Date: August 2016

Check-Up Visits
Regular check-up examinations by your eye care practitioner are an important and ongoing part of wearing your Vertex, Vertex Toric, and Vertex Toric XR contact lenses. Keep all appointments for check-up visits.
Appointment Schedule
Your appointments are on:

DATE

TIME

HOURS*

*Minimum number of hours lenses are to be worn at time of appointment.
PATIENT/EYE CARE PRACTITIONER INFORMATION Name of Practitioner: Address: Phone: Recommended Lens Care Regimen: Other Information:

IMPORTANT: In the event that you experience any difficulty wearing your contact lenses or you do not understand the instructions given you, DO NOT WAIT for your next appointment. TELEPHONE YOUR EYE CARE PRACTITIONER IMMEDIATELY.
NAME AND ADDRESS OF MANUFACTURER CooperVision, Inc. 711 North Road Scottsville, NY 14546
For Package Insert please reference PI01012.

Part Number: PIB01024 Revision A

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