Owner manual

CAUTION
Federal (U.S.A.) law restricts this device to sale by or on the order of a licensed
practitioner.
IMPORTANT
This package insert and fitting guide has been developed to provide practitioners
with information covering characteristics of the Bausch + Lomb Ultra (samfilcon A)
Visibility Tinted Soft (hydrophilic) Contact Lens and to illustrate fitting procedures.
It is effective as of September 2013 and supersedes all prior fitting guides for the
product described. Please read carefully and keep this information for future use.
This package insert and fitting guide is intended for the eye care professional, but
should be made available to patients upon request. The eye care professional
should provide the patient with the patient instructions that pertain to the patient’s
prescribed lens and the recommended wearing schedule.
TABLE OF CONTENTS
Important 2
Description 3
Lens Parameters Available 4
How the Lens Works (Actions) 4
Indications 5
Contraindications (Reasons Not To Use) 6
Warnings 7
Precautions 8
Adverse Reactions 12
Selection of Patients 14
Fitting Procedure 15
Pre-Fitting Examination 15
Initial Lens Power Selection 15
Initial Lens Evaluation 16
Criteria of a Well-fitted Lens 16
Characteristics of a Tight (Steep) Lens 17
Characteristics of a Loose (Flat) Lens 17
Follow-up Care 18
Practitioner Fitting Sets 20
Wearing Schedule 20
Monovision Fitting Guidelines 21
Patient Selection 21
Eye Selection 22
Special Fitting Considerations 23
Near Add Determination 23
Trial Lens Fitting 24
Adaptation 25
Other Suggestions 26
Handling of Lens 27
Patient Lens Care Directions 27
Frequent/Planned Replacement Wear 27
Disposable Wear 27
Care for a Sticking (Nonmoving) Lens 28
Reporting of Adverse Reactions 39
How Supplied 30
SYMBOL REFERENCE GUIDE
For labels and cartons:
Quality System Certification Symbol
Fee Paid for Waste Management
Sterile Using Steam or Dry Heat
See Instruction Leaflet
Diameter
Use by Date (Expiration Date)
Batch Code
Authorized Representative in European Community
Caution: Federal law restricts this device to sale by or
on the order of a licensed practitioner
Diopter (Lens Power)
Base Curve
Storage Temperature
PACKAGE INSERT / FITTING GUIDE
© Bausch & Lomb Incorporated. All rights reserved worldwide.
®/TM are trademarks of Bausch & Lomb Incorporated or its affiliates.
Other product/brand names are trademarks of their respective owners.
Name and Address of Manufacturer:
Bausch & Lomb Incorporated
1400 North Goodman Street
Rochester, New York, USA 14609
Printed in the U.S.A.
CAUTION: Federal law restricts this device to
sale by or on the order of a licensed practitioner.
DESCRIPTION
The Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic)
Contact Lens is a soft hydrophilic contact lens which is available as a spherical lens.
The lens material, samfilcon A, is a hydrophilic copolymer of a siloxane methacrylate
and N-vinyl pyrrolidone, and is 46% water by weight when immersed in a sterile
borate buffered saline with poloxamine solution. This lens is tinted blue with up to
200 ppm of Reactive Blue Dye 246.
The physical / optical properties of the lens are:
Specific Gravity: 1.048
Refractive Index: 1.411
Light Transmittance: C.I.E. value—at least 95%
Water Content: 46%
Oxygen Permeability: 114x 10
–11
[cm
3
O
2
(STP) x cm]/(sec x cm
2
x mmHg)
@ 35° C Polarographic Method
(Boundary and Edge Corrected)
The Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic)
Contact Lenses, with samfilcon A lens material, are manufactured by the
MositureSeal™ manufacturing process, which combines lens molding through
packaging in a continuous fashion by a cast molding process which creates a
hydrophilic surface.
The Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic)
Contact Lenses may be prescribed for Frequent/Planned Replacement or
Disposable Wear.
LENS PARAMETERS AVAILABLE
The Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact
Lens is a hemispherical shell of the following dimensions:
Diameter: 14.2mm
Center Thickness: 0.05mm to 0.50mm
Base Curve: 8.5mm
Powers (Spherical): +6.00D to -12.00D*
*
Additional powers may be introduced over time, check periodically for product availability.
HOW THE LENS WORKS (ACTIONS)
In its hydrated state, the Bausch + Lomb Ultra (samfilcon A) Visibility Tinted
Soft (hydrophilic) Contact Lens when placed on the cornea acts as a refracting
medium to focus light rays on the retina.
INDICATIONS
Vision Correction
The Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic)
Contact Lens is indicated for daily wear for the correction of refractive ametropia
(myopia, hyperopia) in aphakic and/or not-aphakic persons with non-diseased
eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with
visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear
or Disposable Wear in spherical powers ranging from +20.00D to –20.00D for
daily wear.
Frequent/Planned Replacement Wear
When prescribed for Frequent/Planned Replacement Wear, the Bausch +
Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lens is to
be cleaned, rinsed and disinfected each time it is removed from the patient’s eye
and discarded after the recommended wearing period prescribed by the eye care
professional. The lens may be disinfected using a chemical disinfection system.
Disposable Wear
When prescribed for Disposable Wear, the Bausch + Lomb Ultra (samfilcon
A) Visibility Tinted Soft (hydrophilic) Contact Lens is to be discarded after each
removal.
CONTRAINDICATIONS
(REASONS NOT TO USE)
DO NOT USE the Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft
(hydrophilic) Contact Lens 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 that affects the cornea, conjunctiva, or
eyelids
• Severe insufficiency of lacrimal secretion (dry eyes)
• Corneal hypoesthesia (reduced corneal sensitivity)
• Any systemic disease that may affect the eye or be exaggerated by wearing
contact lenses
• Allergic reactions of ocular surfaces or adnexa (surrounding tissue) 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 the Bausch + Lomb Ultra (samfilcon A) Visibility Tinted
Soft (hydrophilic) Contact Lens
• Any active corneal infection (bacterial, fungal, or viral)
• If eyes become red or irritated
WARNINGS
After a thorough eye examination, including appropriate medical background,
patients should be fully apprised by the prescribing professional of all the risks
with contact lens wear. Patients 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 patients follow their eye care professional’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.
• 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 adverse reactions is increased when daily wear lenses are worn
overnight.
• When prescribed for Frequent/Planned Replacement Wear, the need for
strict compliance with the care regimen including cleaning of the lens case,
wearing restrictions, wearing schedule, and follow-up visit schedule should be
emphasized to the patient.
• Studies have shown that contact lens wearers who are smokers have a higher
incidence of adverse reactions than nonsmokers.
PRECAUTIONS
Special Precautions for Eye Care Professionals
• 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 significant numbers.
Consequently, when selecting an appropriate lens design and parameters,
the eye care professional 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 patient’s need for refractive correction; therefore,
the prescribing eye care professional should carefully monitor the continuing
ocular health of the patient and lens performance on eye.
• Eye care professionals should instruct the patient to REMOVE A LENS
IMMEDIATELY if an eye becomes red or irritated.
• Fluorescein, a yellow dye, should not be used while the lenses are on the eyes.
The lenses absorb this dye and become discolored. Whenever fluorescein
is used in eyes, the eyes should be flushed with sterile saline solution that is
recommended for in-eye use.
• The patient should be instructed to always discard disposable lenses and lenses
worn on a frequent/planned replacement schedule after the recommended
wearing schedule prescribed by the eye care professional.
• 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.
• Aphakic patients should not be fitted with Bausch + Lomb Ultra (samfilcon
A) Visibility Tinted Soft (hydrophilic) Contact Lenses until the determination is
made that the eye has healed completely.
Handling Precautions
• Always wash and rinse hands before handling 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-base cosmetics are
less likely to damage lenses than oil-base products.
• Be sure that before leaving the eye care professional’s office, the patient is able
to remove lenses promptly or have someone else available to remove them.
• Be certain that the fingers or hands are free of foreign materials before touching
lenses, as microscopic scratches of the lenses may occur, causing distorted
vision and/or injury to the eye.
• Always handle lenses carefully and avoid dropping them.
• Do not touch the lens with fingernails.
• Carefully follow the handling, insertion, removal, cleaning, disinfecting, storing
and wearing instructions in the Patient Information Booklet for the Bausch +
Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lens and
those prescribed by the eye care professional.
• 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.
Solution Precautions
Eye injury due to irritation or infection may result from lens contamination. To reduce
the risk of contamination, review the appropriate manufacturer’s labeled lens care
instructions with the patient.
• 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.
• You should fill your lens case with fresh solution every time you store your
lenses, and never “top-off” or re-use solution. You should discard your solution
immediately after your lenses have been removed from the lens case.
• Always keep the lenses completely immersed in the recommended storage
solution when lenses are not being worn (stored). Prolonged periods of drying
will damage lenses. Follow the lens care directions for Care for a Dried Out
(Dehydrated) Lens in the Patient Information Booklet if lens surface does
become dried out.
• Do not use saliva or anything other than the recommended solution for
lubricating or wetting lenses.
• Tap water, distilled water or homemade saline should not be used as a substitute
for any component in the lens care regimen since they have been associated
with an Acanthamoeba keratitis infection.
• Never use conventional hard contact lens solutions that are not also
recommended for use with prescribed lenses.
• Do not mix or alternate lens care systems or solutions unless indicated in the
lens care system labeling.
• Do not heat the chemical disinfection solution or lenses.
Lens Wearing Precautions
• Never wear lenses beyond the period recommended by the eye care
professional.
• 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, the patient
should be instructed to immediately consult his or her eye care professional.
• Avoid, if possible, all harmful or irritating vapors and fumes while wearing lenses.
• If aerosol products are used while wearing lenses, exercise caution and keep
eyes closed until the spray has settled.
Lens Case Precautions
• Contact lens cases can be a source of bacterial growth. To prevent
contamination and to help avoid serious eye injury, always empty and rinse the
lens case with fresh, sterile rinsing solution and allow to air dry.
• Lens cases should be replaced at regular intervals as recommended by the lens
case manufacturer or eye care professional.
Topics to Discuss with the Patient
• As with any contact lens, follow-up visits are necessary to assure the continuing
health of the eyes. The patient should be instructed as to a recommended
follow-up schedule.
• Patients should be advised about wearing lenses during sporting and water
related activities. Exposure to water while wearing contact lenses in activities
such as swimming, water skiing and hot tubs may increase the risk of ocular
infection including but not limited to Acanthamoeba keratitis.
• Always contact the eye care professional before using any medicine in the eyes.
Who Should Know That the Patient is Wearing Contact Lenses
• Patients should inform their doctor (health care professional) about being a
contact lens wearer.
• Patients should always inform their employer of being a contact lens wearer.
Some jobs may require the use of eye protection equipment or may require that
you do not wear lenses.
ADVERSE REACTIONS
The patient should be informed that 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
• Abnormal feeling of something in the eye (foreign body, 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 the patient notices any of the above, he or she should be instructed to
• Immediately remove the lenses.
• If the discomfort or problem stops, the patient should look closely at the lens. If
the lens is in any way damaged, do not put the lens back on the eye. Place the
lens in the storage case and contact the eye care professional. If the lens has
dirt, an eyelash, or other foreign body on it, or the problem stops and the lens
appears undamaged, the patient should thoroughly clean, rinse, and disinfect
the lenses; then reinsert them. After reinsertion, if the problem continues, the
patient should immediately remove the lenses and consult his or her eye
care professional.
If the above symptoms continue after removal of the lens, or upon reinsertion
of a lens, or upon insertion of a new lens, the patient should immediately
remove the lenses and contact his or her eye care professional or
physician, who must determine the need for examination, treatment or referral
without delay. (See Important Treatment Information for Adverse Reactions.)
A serious condition such as infection, corneal ulcer, corneal vascularization, or
iritis may be present, and may progress rapidly. Less serious reactions such as
abrasions, epithelial staining or bacterial conjunctivitis must be managed and
treated carefully to avoid more serious complications.
Important Treatment Information for Adverse Reactions
Sight-threatening ocular complications associated with contact lens wear can
develop rapidly, and therefore early recognition and treatment of problems
are critical. Infectious corneal ulceration is one of the most serious potential
complications, and may be ambiguous in its early stage. Signs and symptoms
of infectious corneal ulceration include discomfort, pain, inflammation, purulent
discharge, sensitivity to light, cells and flare, and corneal infiltrates.
Initial symptoms of a minor abrasion and an early infected ulcer are sometimes
similar. Accordingly, such epithelial defect, if not treated properly, may develop
into an infected ulcer. In order to prevent serious progression of these conditions,
a patient presenting symptoms of abrasions or early ulcers should be evaluated as
a potential medical emergency, treated accordingly, and be referred to a corneal
specialist when appropriate. Standard therapy for corneal abrasions such as eye
patching or the use of steroids or steroid/antibiotic combination may exacerbate
the condition. If the patient is wearing a contact lens on the affected eye when
examined, the lens should be removed immediately and the lens and lens care
products retained for analysis and culturing.
SELECTION OF PATIENTS
The eye care professional should not fit patients who cannot or will not adhere to a
recommended care or replacement regimen, or are unable to place and remove
the lenses should not be provided with them. Failure to follow handling and cleaning
instructions could lead to serious eye infections which might result in corneal ulcers.
Patient communication is vital because it relates not only to patient selection but also
to ensure compliance. It is also necessary to discuss the information contained in the
Patient Information Booklet with the patient at the time of the initial examination.
Patients selected to wear Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft
(hydrophilic) Contact Lenses should be chosen for their motivation to wear contact
lenses, general health and cooperation. The eye care professional must take care
in selecting, examining and instructing contact lens patients. Patient hygiene and
willingness to follow practitioner instructions are essential to their success.
A detailed history is crucial to determining patient needs and expectations. Your
patient should be questioned regarding vocation, desired lens wearing time (full or
part time), and desired lens usage (reading, recreation or hobbies).
Initial evaluation of the trial lens should be preceded by a complete eye examination,
including visual acuity with and without correction at both distance and near,
keratometry and slit lamp examination.
It is normal for the patient to experience mild symptoms such as lens awareness,
variable vision, occasional tearing (watery eyes) and slight redness during the
adaptation period. Although the adaptation period varies for each individual,
generally within one week these symptoms will disappear.
If these symptoms persist, the patient should be instructed to contact his or her eye
care professional.
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Visibility Tinted Soft (hydrophilic)
Contact Lenses
SL7356
8119500