Bausch-lomb SofLens Multi-Focal Contact Lenses User Manual download pdf

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

/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

(STP) x cm]/(sec x cm

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

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

1 2 3 4

Summary of Contents

Page 1

Visibility Tinted Contact LensesIMPORTANTThis package insert and fitting guide has been developed to provide professionals with information covering c

Page 2

Visibility Tinted Contact LensesIMPORTANTThis package insert and fitting guide has been developed to provide professionals with information covering c

Page 3

3. Initial Lens Evaluationa. To determine proper lens parameters observe the lens relationship to the eye using a slit lamp.• Movement: The lens sho

Page 4

3. Initial Lens Evaluationa. To determine proper lens parameters observe the lens relationship to the eye using a slit lamp.• Movement: The lens sho

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Bausch-lomb SofLens Multi-Focal Contact Lenses User Manual

Browse online or download User Manual for Health and hygiene Bausch-lomb SofLens Multi-Focal Contact Lenses. Bausch &amp; Lomb SofLens Multi-Focal Contact Lenses User Manual [de]

Summary of Contents

Comments to this Manuals

Related products and manuals for Health and hygiene Bausch-lomb SofLens Multi-Focal Contact Lenses

Browse online or download User Manual for Health and hygiene Bausch-lomb SofLens Multi-Focal Contact Lenses. Bausch & Lomb SofLens Multi-Focal Contact Lenses User Manual [de]