Bausch & Lomb SofLens Multi-Focal Contact Lenses - Manual

Visibility Tinted Contact Lenses
IMportant
This package insert and fitting guide has been developed to provide professionals
with information covering characteristics of the Bausch + Lomb ® SofLens ®
Multi-Focal (polymacon) Visibility Tinted Contact Lens and to illustrate fitting
procedures. It is effective as of September 2014 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
3
How the Lens Works (Actions) 4
Indications 4
Contraindications (Reasons Not To Use)
5
Warnings 6
Precautions 7
Adverse Reactions
10
Important Treatment Information for Adverse Reactions 11
Selection of Patients 12
Fitting Procedure 13
Pre-Fitting Examination 13
Initial Lens Power Selection 14
Initial Lens Evaluation 15
Criteria of a Well-Fitted Lens 15
Characteristics of a Tight (Steep) Lens 15
Characteristics of a Loose (Flat) Lens 15
Follow-up Care 16
Professional Fitting Sets 17
Wearing Schedule 17
Multi-Focal Fitting Guidelines 17
Patient Selection 17
Lens Selection 17
Lens Fitting 18
Symptom Resolution 18
Patient Education 19
Monovision Fitting Guidelines 19
Patient Selection 19
Eye Selection 20
Special Fitting Considerations 20
Near Add Determination 21
Trial Lens Fitting 21
Adaptation 22
Other Suggestions 23
Handling of Lenses 24
Care for a Sticking (Nonmoving) Lens 24
Care for a Dried Out (Dehydrated) Lens 25
Emergencies 25
Reporting of Adverse Reactions
26
How Supplied 26
PACKAGE INSERT / FITTING GUIDE
© Bausch & Lomb Incorporated. All rights reserved worldwide.
® /TM are trademarks of Bausch & Lomb Incorporated or its affiliates.
Bausch & Lomb Incorporated
Rochester, New York, USA 14609
Printed in U.S.A.
SL7484
8004904
CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the
order of a licensed professional.
DescrIptIon
The Bausch + Lomb SofLens ® Multi-Focal (polymacon) Visibility Tinted Contact
Lens is a soft hydrophilic contact lens that is a front surface asphere consisting of
multiple aspheric zones with a spherical base curve. The most plus power is in the
center of the lens, progressing to more minus in the periphery. The lens material,
polymacon, is 2-hydroxyethyl methacrylate, and is 38.6% water by weight when
immersed in a sterile saline solution. This lens is tinted blue with up to 100 ppm of
Reactive Blue Dye 246.
The physical/optical properties of the lens are:
Specific Gravity:
1.12
Refractive Index: 1.43
Light Transmittance: C.I.E. value—at least 86%
Water Content: 38.6%
Oxygen Permeability: 8.4 x 10 –11 [cm 3 O
2
(STP) x cm]/(sec x cm 2 x mmHg) @
35° C
Polarographic Method (Boundary and Edge
Corrected)
The SofLens ® Multi-Focal Contact Lenses are manufactured by a cast molding
process.
The SofLens
® Multi-Focal Contact Lens may be prescribed for Frequent/Planned
Replacement or Disposable Wear.
lens paraMeters aVaIlable
The Bausch + Lomb SofLens ® Multi-Focal (polymacon) Visibility Tinted Contact
Lens is a hemispherical shell of the following dimensions:
Diameter: 14.5mm
Center Thickness:
0.05mm to 0.50mm
Base Curve: 8.5mm and 8.8mm
Powers (Spherical): +6.00D to –10.00D (0.25D increments)
Add Powers: Low (+0.75D to +1.50D) and High (+1.75D to +2.50D)
HoW tHe lens WorKs (actIons)
In its hydrated state, the Bausch + Lomb SofLens Multi-Focal (polymacon) Visibility
Tinted Contact Lens when placed on the cornea acts as a refracting medium to focus
light rays on the retina.
InDIcatIons
Bausch + Lomb SofLens ® Multi-Focal (polymacon) Visibility Tinted Contact Lens is
indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia,
and astigmatism) and presbyopia 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 provides a power range of +20.00 to -20.00 diopters with
add power ranging from +1.00D to +5.00D.
Replacement schedules may vary from patient to patient, and should be decided by
eye care professionals in consultation with their patients. The 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.
Frequent/Planned Replacement Wear
When prescribed for Frequent/Planned Replacement Wear, the SofLens
® Multi-Focal
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 SofLens
® Multi-Focal Contact Lens is to
be discarded after each removal.
contraInDIcatIons
(reasons not to Use)
DO NOT USE the Bausch + Lomb SofLens ® Multi-Focal (polymacon) Visibility Tinted
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 SofLens Multi-Focal (polymacon) Visibility
Tinted 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 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 serious adverse reactions is increased when daily wear
lenses are worn overnight.
• 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.
• If a patient experiences eye discomfort, excessive tearing, vision changes, or
redness of the eye, the patient should be instructed to immediately remove
lenses and promptly contact his or her eye care professional.
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.
• Patients who wear aspheric contact lenses, such as the SofLens ® Multi-Focal
Contact Lens, to correct presbyopia may not achieve the best corrected
visual acuity for either far or near vision. Visual requirements vary with the
individual and should be considered when selecting the most appropriate
type of lens for each patient.
• 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 SofLens ® Multi-Focal Contact
Lenses until the determination is made that the eye has healed completely.
Eye care professionals should carefully instruct patients about the following
lens care and safety precautions. It is strongly recommended that patients
be provided with a copy of the SofLens Multi-Focal Contact Lens Patient
Information Booklet available from Bausch + Lomb and understand its
contents prior to dispensing the lenses.
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 SofLens ® Multi-
Focal Contact Lenses 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
• 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.
• 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 use chemical disinfection solutions with heat unless specifically indicated
on product labeling for use in both heat and chemical disinfection.
Lens Wearing Precautions
• 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.
• 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 use chemical disinfection solutions with heat unless specifically indicated
on product labeling for use in both heat and chemical disinfection.
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, then 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 stinging 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 combinations 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 SofLens
® Multi-Focal 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 professional 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.
fIttInG proceDUre
1. Pre-Fitting Examination
A pre-fitting patient history and examination are necessary to:
• determine whether a patient is a suitable candidate for contact lenses
(consider patient hygiene and mental and physical state),
• make ocular measurements for initial contact lens parameter selection, and
• collect and record baseline clinical information to which post-fitting
examination results can be compared.
A prefitting examination should include spherocylinder refraction and VA,
keratometry, and biomicroscopic examination.
2. Initial Lens Power Selection
a. Perform a preliminary evaluation to determine distance refraction and near
add requirements.
b. Determine patient’s spherical equivalent refractive error corrected to the
corneal plane.
c. For each eye, select a lens of the power closest to the patient’s spherical
equivalent distance Rx.
d. Select the appropriate ADD.
• Bausch + Lomb SofLens ® Multi-Focal Low ADD: +0.75 to +1.50D.
• Bausch + Lomb SofLens ® Multi-Focal (polymacon) High ADD: +1.75 to
+2.50D.
e. Measure binocular near and distance VA.
f. Make adjustments in power as necessary. The use of hand held trial lenses will
simplify fitting and minimize lens changes. To improve near vision, add plus in
+0.25D increments to both eyes. If distance vision becomes unacceptable
with this change, add plus to the non-dominant eye only. Measure near,
then distance VA binocularly then monocularly. To improve distance vision,
add minus in –0.25D increments in both eyes. If near vision becomes
unacceptable with this change, add minus to the dominant eye only. Measure
distance, then near VA, binocularly then monocularly.
g. Make final lens changes and confirm acuity. Attempt to minimize any resultant
binocular imbalance.
Demonstrate vision:
• under normal conditions
• at near in any position of gaze
• in decreased illumination
• at intermediate distances
2
6
10
14
5
9
13
4
8
12
3
7
11
syMbol reference GUIDe
For label 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)
Diopter
(Lens Power)
Batch Code
Authorized
Representative
in European
Community
Caution: Federal
law restricts this
device to sale by
or on the order
of a licensed
professional
Base Curve
Storage
Temperature