Bausch & Lomb SofLens Multi-Focal Contact Lenses User Manual

PACKAGE INSERT / FITTING GUIDE

Visibility Tinted Contact Lenses

CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a licensed professional.

/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

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

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

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.

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

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:

–11

[cm3O2(STP) x cm]/(sec x cm2 x mmHg) @ 35° C Polarographic Method (Boundary and Edge Corrected)

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 nondiseased 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 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.

Multi-

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.

• Do not use saliva or anything other than the recommended solution for lubricating or wetting lenses.

• 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 followup 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

• 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

Multi-Focal Low ADD: +0.75 to +1.50D.

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Bausch & Lomb SofLens Multi-Focal Contact Lenses User Manual

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