CooperVision ICD 16.5Sph User manual

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RGP Contact Lenses
Instruction For Use
Manufacturer and registered owner: CooperVision Israel Ltd, Bar-Lev, 2015600, IL
Telephone number: 04-9955600
General Inquiries & Technical Support: [email protected]
CooperVision CL Kft.
Gorcsev Iván street 7. Building C. 2360 Gyál Hungary
All information in this manual is believed to be correct. CooperVision shall not be liable for
errors contained herein with the performance or use of this manual.
1. Introduction
This operator’s manual provides the information necessary to safely wear of RGP Contact
Lenses for annual replacement schedule.

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Carefully read this operator’s manual and the instructions for use for wearing the RGP
Contact Lenses.
2. Device description
The RGP contact lenses are Rigid Gas Permeable lenses that allow oxygen to reach the clear
front surface (cornea) of the eye. This flow of oxygen contributes to the health and comfort
of the eye.
Product name, Indications and Trade name -
RGP Lenses - Group
Name
Indications
Trade Name
ICD
Rigid-gas-
permeable
corrective contact
lens,
Daily-wear
Trade Name
Article no.
ICD 16.5Sph
6010
ICD 14.5Mini
6009
ICD16.5 Toric
6011
ICDFF14.8
6012
ICDFF14.8DDT
6054
ICDFF16.3DD
6013
ICDFF16.3DDT
6014
OneFit
Trade Name
Article no.
Onefit
6020
OneFitMED
Trade Name
Article no.
Onefit Med
6021
OneFitMPlus
6022
Spheric
Trade Name
Article no.
NATURALENS
6018
OP2
6023
OP5
6025
OP8
6027
SKI
6037
SOFLEX ND
6048
TRI
6052
SPECIAL HARD
6050
McGlobus
6015
McNipple
6016
McOval
6017
Front Toric
Trade Name
Article no.
OPT2FT
6024
OP5FT
6026
SKIFT
6038
OP8FT
6028

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NaturalFT
6019
SoflexNDFT
6049
SPEHARD-FT
6051
Back Toric
Trade Name
Article no.
OPT
6031
OPTLITE
6032
OPT PERIPHERY
6033
Ortho-K
Rigid-gas-
permeable
Orthokeratology
contact lens
Overnight wear
Trade Name
Article no.
OVERNIGHT
6035
OVERNIGHTSt
6036
Orthotool
6034
CRT
Trade Name
Article no.
Paragon CRT100
6002
Paragon CRTDA
6003
3. Intended use/indication
Daily wear RGP Contact Lenses are intended to be used for daily wear (or as directed by the
Eye Care Practitioner) when placed on the eye, the lens focuses light onto the Retina at an
angle that can correct ametropia, such as: nearsightedness, farsightedness and astigmatism.
Orthokeratology RGP Contact Lenses are indicated for use in the reduction of myopic
refractive error in non-diseased eyes. The lenses are indicated for overnight wear in a
Corneal Refractive Therapy fitting program for the temporary reduction and control of
myopia.
Each lens is prescribed by Eye Care Practitioner (ECP), optometrist or ophthalmologist
according to his knowledge, experience and expertise.
There are no age limitations for contact lenses as long its prescribed by Eye Care Practitioner
(ECP), optometrist or ophthalmologist.
4. Packaging
Each lens is supplied dry in a mailer/vial.
5. Storage
No special storage conditions.
6. Contraindications

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There are certain health conditions in which RGP contact lenses should not be worn. You
should alert your eye care practitioner to any of the conditions listed below. Only your eye
care practitioner can determine if contact lens wear is right for you.
•If eyes become red or irritated.
•Acute inflammation or infection of the anterior chamber of the eye.
•Any eye disease, injury, or abnormality that effects the cornea, conjunctiva, or
eyelids.
•Insufficiency of lachrymal secretion (dry eyes).
•Corneal hypoesthesia (reduced corneal sensitivity).
•Any systemic disease that may affect the eye or be exaggerated by wearing contact
lenses.
•Allergic reaction 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
•Any active corneal infection (bacterial, fungal, or viral).
7. Warning and Precaution
The safety information should be read carefully and understood prior to wearing the RGP
Contact Lenses.
In the event of improper response, advise with your eye care practitioner.
Warning:
•Direct exposure of contact lenses to non-sterile water (e.g. tap water, whirlpool
bath, swimming, participating in water sports) increases the risk of microbial
infection.
•Problems with contact lenses and lens care products could result in seriously injury
to the eye. It is essential that patients follow their eyecare practitioner's direction
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.
•Always inspect lenses carefully after disinfecting and cleaning and before inserting
them in the eye. Injury can result if cracked or chipped lenses are inserted in the eye.
•Daily wear lenses are not indicated for overnight wear and patients should be
instructed not to wear lenses while sleeping. Clinical studies have shown that the risk
of serious adverse reactions is increased when these lenses are worn overnight
(unless instructed by your ECP).
Precaution:

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•Due to the small number of patients enrolled in clinical investigation of lenses, all
refractive powers, design configurations, or lens parameters available in the lens
material are not evaluated in signification numbers. Consequently, when selecting an
appropriate lens design and parameters, the eyecare practitioner should consider all
characteristics of the lens that can affect lens performance and ocular health,
including oxygen permeability, wettability, central and peripheral thickness, and
optic zone diameter.
The potential impact of these factors on the patient's ocular health should be carefully
weighed against the patients need for refractive correction; therefore, the continuing
ocular health of the patient and lens performance on the eye should be carefully
monitored by the prescribing eyecare practitioner.
•Aphakic patients should not be fitted with Contact Lenses until the determination is
made that the eye has healed completely.
•Fluorescein, a yellow dye, can be used to observe lens fitting and cornea problems.
•Before leaving the eyecare practitioner's office the patient should be able to
promptly remove lenses or should have someone else available who can remove the
lenses for him or her.
•Eyecare practitioners should instruct the patient to remove the lenses immediately if
the eye becomes red or irritated.
•Your eyecare practitioner will recommend a wearing regime, but in doubt do ask him
for advice. Always follow his recommendations and make regular visits.
Eyecare practitioners should carefully instruct patients about the following care regimen
and safety precautions:
•Direct exposure of contact lenses to non-sterile water (e.g. tap water, whirlpool
bath, swimming, participating in water sports) increases the risk of microbial
infection.
•Use only solutions recommended by your eyecare practitioner's. Different solutions
cannot always be used together, and not all solutions are safe for use with all lenses.
•Always use fresh unexpired lens care solutions.
•Always follow directions in the instruction for use 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.
•Always keep the lenses completely immersed in the recommended storage when the
lenses are not being worn (stored).

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•Inspect lenses before inserting them in the eye. The patient should be instructed
how to inspect their lenses with examples of intact, chipped, and cracked lenses.
•If the lens sticks (stop moving) on the eye, follow the recommended directions on
CARE FOR A STICKING LENS. The lens should move on the eye for the continued
health of the eye. If non-movement of the lens continues, the patient should be
instructed to immediately consult his or her eyecare practitioner.
•Always wash and rinse hands before handling lenses. Do not get cosmetics, lotions,
soap, creams, deodorant, or sprays in the eyes or on the lenses. It is best to put on
lenses before putting on makeup. Water-base cosmetics are less likely to damage
lenses than oil-base products.
•Do not touch contact lenses with the fingers or hands if the hands are not free of
foreign materials, as microscopic scratches of the lenses may occur causing distorted
vision and / or injury to the eye.
•Carefully follow the handling, insertion, removal, cleaning, disinfecting, storing and
wearing instructions in the Instructions for use of RGP Contact Lens for Daily Wear or
Overnight Wear RGP Contact Lens, as recommended by the ECP.
•Never wear lenses beyond the recommended period.
•If aerosol products such as hair spray are used while wearing lenses, keep eyes
closed until the spray has settled.
•Always handle lenses gently and do not squeeze the lenses.
•Avoid all harmful or irritating vapors and fumes while wearing lenses.
•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.
•Consult the eyecare practitioner before using any medicine in the eyes.
•Always inform your employer of being a contact lens wearer. Some jobs may require
use of eye protection equipment or may require that the patient not wear contact
lenses.
•As with any contact lens, follow-up visits are necessary to assure the continuing
health of the patient's eyes. The patient should be instructed as to a recommended
follow-up schedule.
Note: The lenses are for your personal use only.
8. Restriction on use
Always wash thoroughly and dry your hands before handling your lenses. Initially clean the
lenses and soak them for at least 2 hours before insertion.
9. Adverse Events

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You should be aware of the following problems that may occur:
•Eye pain
•Eye's sting, burn or itch (irritation)
•Comfort is less than when is your lens was first placed on your eyes.
•Abnormal feeling of something in your eye (foreign body, scratched area)
•Excessive watering (tearing) of your eyes.
•Unusual eye secretions.
•Redness of your 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 YOU SHOULD IMMEDIATELY REMOVE YOUR LENSES
•If the discomfort stops, examine your lenses closely:
-If your lens is damaged in any way, do not put the lens back on your eye. Place
the lens in the storage case and contact your eye care practitioner.
-If your lens has dirt, an eyelash, or other foreign body on it and the lens appears
undamaged, you should thoroughly clean, rinse, and disinfect the lens, 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.
10. Fitting
Lenses are fitted by the ECP for the user to ensure healthy vision and comfortable wears.
11. Operating procedure
11.1. Right and Left Lens Insertion
•Place the lens on your right-hand Index finger and verify the shape.
•Hold up the upper lid using your left hand's index and second finger whilst
holding down the lower lid with your right hand's second finger. You can
now place the lens onto the eye.
11.2. Lens Removal
1. Work over a table with a clean towel. Do not remove lenses over a sink.

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2. Place the right index finger at the outer corner of the eye.
3. Place the left hand cupped below the eye.
4. Open the eyes wide as if to stare.
5. Continue to keep the eyes open and pull the lids sideways away from nose.
6. Blink quickly and firmly.
Remove the second lens by following the same procedure.
12. Wearing Schedule
•The eyecare practitioner should determine the wearing and replacement schedules.
Patients tend to over wear the lenses initially. The eyecare practitioner should
emphasize the importance of adhering to the initial maximum wearing schedule.
Regular checkups, as determined by the eyecare practitioner, are also extremely
important.
1. Daily Wear RGP Contact Lenses. The maximum suggested wearing time for the lenses is:
DAY
HOURS
1
(4)
2
(5)
3
(6)
4
(7)
5
(8)
6
(9)
7
(10)
8
(11)
9
(12)
10 and after
All working hours
2. Orthokeratology RGP Contact Lenses
The following sequence is recommended as a guideline. Patients are cautioned to limit the
wearing schedule recommended by the eye care practitioner.
It is ideal for the patient to start with overnight wear the first night. Patients should be
instructed to place the lens on the eye 15 to 20 minutes before going to sleep. It is
important that the new wearer not sleep in a lens that has a significant foreign body

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sensation. In the event of foreign body sensation,
the patient should remove the lens, clean and rewet it and replace the lens. If the sensation
continues, the lens should not be worn.
The patient should report for follow-up evaluation the morning after the first overnight
wear. The visit is best scheduled within a few hours of
awakening and the patient should report with the lens in place.
An alternate initial daytime wear schedule may be offered at the practitioner’s discretion.
Day 1: two periods of wear not to exceed 6 hours total
Day 2: 6 hours
Day 3-5: 8 hours
Day 6: overnight wear with follow-up visit within 24 hours.
The cornea normally changes within five to eight hours of wear. The wearing schedule
should be modulated to determine the MINIMUM wear required for myopic reduction. The
average wearing time is between 8 and 10 hours. Attempt to maintain wearing time at this
level.
13. Disinfecting / Soaking Handling
1. After cleaning the lenses, disinfect them using FRESH solutions as directed by your
practitioner. This kills potentially harmful bacteria and fungi, on the lenses.
2. Follow the instructions on the bottles regarding soaking time and procedures,
3. DO NOT shortcut this step, and NEVER re-use solutions. Pay attention to the
expiry date of the solution.
14. Lens Care Directions
Eyecare practitioners should review with the patient lens care directions, including both
basic lens care information and specific instructions on the lens care regiment
recommended for the patient:
General Lens Care (First Clean and Rinse, Then Disinfect Lenses)
•Always wash thoroughly, rinse and dry hands before handling contact lenses.
•Always use fresh unexpired lens care solutions. Never re-use solution.
•Use the recommended system of lens care, chemical (not heat) and carefully follow
instructions on solution labeling. Different solutions cannot always be used
together, and not all solutions are safe for use with all the lenses. Do not alternate

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or mix lens care system unless indicated on solution labeling or as recommended by
your eyecare practitioner.
•Always carefully inspect lenses for cracks, or scratches, before inserting them into
the eye. Discomfort and injury may result if cracked or scratched lenses are placed
in the eye.
•Do not use saliva or anything other than the recommended solutions for lubricating
and rewetting lenses. Do not put lenses in the mouth.
•Lenses should be cleaned, rinsed, and disinfected each time they are removed.
Cleaning and rinsing are necessary to remove mucus and film from the lens surface.
Disinfecting is necessary to destroy harmful germs.
•Always remove, clean, rinse, and disinfect lenses according to a schedule prescribed
by your eyecare practitioner. The use of an enzyme or any cleaning solution does
not substitute for disinfecting.
•The eyecare practitioner should recommend a chemical care system (not heat) that
is appropriate for the Contact Lens for Daily Wear. Each lens care product contains
specific directions for use and important safety information, which should be read
and carefully followed.
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 instructions.
Chemical Disinfecting Method:
•Clean one lens first (always the same lens 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, and put the lens into the
correct chamber of the lens storage case. Then repeat the procedure for the second
lens.
•After cleaning, disinfect lenses using the system recommended by the manufacture
and / or eyecare practitioner.
•To store lenses, disinfect and leave them in the closed case until ready to wear.
Lenses stored longer than 72 hours may require cleaning, rinsing and disinfecting
again for use. The patient should consult the instruction for use or the eyecare
practitioner for information on storage of lenses.
•After removing the lenses from the lens case, empty and rinse the lens storage case
with solution as recommended by the lens case manufacturer; then allow the lens
case to air dry. When the case is used again, refill it with fresh disinfecting/storage
solution. Replace lens case at regular intervals.
•Do not heat the disinfecting solution and lenses.

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•Eyecare practitioners may recommend a lubricating / rewetting solution which can
be used to wet (lubricate) lenses while they are being worn to make them more
comfortable.
15. Lens Case Cleaning and Maintenance
Contact lens cases can be a source of bacteria growth. Lens cases should be emptied,
cleaned, rinsed with rinsing solution, and allowed to air dry. Lens cases should be replaced
at regular intervals.
16. Care for a Sticking Lens
If the lens sticks (stops moving), the patient should be instructed to apply 1 to 2 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 non-movement of the lens continues after 5 minutes, the patient should immediately
consult the eyecare practitioner.
17. Instructions of safe disposal
RGP contact lenses shall be disposed annually. No special disposal measures are needed and
the RGP Contact Lenses can be disposed as regular trash.
18. Glossary of Symbols
Symbol
Description
Caution
Medical Device
CE Marking
Authorized representative in the European
Community

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Symbol
Description
Manufacturer
Use-by date
Do not Use if package is damaged and
consult instructions for use
19. Emergencies
Contact lenses should be removed immediately after contact with noxious vapor, e.g.
chemical or hazardous substances, or hazardous environment with ocular impact.
The patient should be informed that if chemicals of any kind (household products,
gardening solutions, laboratory chemicals, etc) are splashed into the eyes, the patients
should flush eyes immediately with tap water and then remove lenses promptly. Contact
the eyecare practitioner or visit a hospital emergency room without delay.
20. REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in wearing the patient
wearing the RGP Contact Lens for daily wear lens (or as directed by the ECP) should be
reported to CooperVision (see details below) and the competent authority of the Member
State in which the user and/or patient is established.
Manufacturer: CooperVision Israel Ltd.
Bar-Lev Industrial park
D.N. Misgav 2015600
ISRAEL
Tel: [phone]

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Fax: [phone]