Bausch & Lomb PureVision2 Contact Lenses User Manual

Package insert / fitting guide

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 PureVision

(balafilcon A) Visibility Tinted Contact Lens and to illustrate fitting procedures. It

is effective as of November 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

How the Lens Works (Actions)

Indications 4
Contraindications (Reasons Not To Use)

Warnings 7
Precautions 9
Adverse Reactions

Clinical Studies

Selection of Patients

Fitting Procedure

Pre-Fitting Examination

Initial Lens Power Selection

Initial Lens Evaluation

Criteria of a Well-Fitted Lens

Characteristics of a Tight (Steep) Lens

Characteristics of a Loose (Flat) Lens

Follow-up Care

Practitioner Fitting Sets

Wearing Schedule

Monovision Fitting Guidelines

Patient Selection

Eye Selection

Special Fitting Considerations

Near Add Determination

Trial Lens Fitting

Adaptation

Other Suggestions

Handling of Lens

Patient Lens Care Directions

Frequent/Planned Replacement Wear

Disposable Wear

Therapeutic Wear

Care for a Sticking (Nonmoving) Lens

Reporting of Adverse Reactions

How Supplied

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

®/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

Rochester, New York, USA 14609

Printed in the U.S.A.

SL7385-1

8067601

CAUTION: Federal law restricts this device to

sale by or on the order of a licensed practitioner.

desCRIPTION

The Bausch + Lomb PureVision

2 (balafilcon A) Visibility Tinted Contact Lens is a

soft hydrophilic contact lens which is available as a spherical lens. The lens material,

balafilcon A, is a copolymer of a silicone vinyl carbamate, N-vinyl-pyrrolidone, a

siloxane crosslinker and a vinyl alanine wetting monomer, and is 36% water by

weight when immersed in a sterile borate buffered saline solution. This lens is tinted

blue with up to 300 ppm of Reactive Blue Dye 246.
The physical / optical properties of the lens are:
Specific Gravity:

1.064

Refractive Index:

1.426

Light Transmittance:

C.I.E. value—at least 95%

Water Content:

36%

Oxygen Permeability:

91 x 10

–11

[cm

(STP) x cm]/(sec x cm

x mmHg)

@ 35° C Polarographic Method

(Boundary and Edge Corrected)

101 x 10

–11

[cm

(STP) x cm]/(sec x cm

mmHg) @ 35°C Polarographic Method

(Boundary Corrected, Non-Edge Corrected)

The Bausch + Lomb PureVision

2 (balafilcon A) Visibility Tinted Contact

Lenses, with AerGel™ technology lens material, are manufactured by the

FormCast™ manufacturing process, cast molding process, and are surface

treated by the Performa™ surface treatment process which transforms

hydrophobic silicone to hydrophilic silicate.
The Bausch + Lomb PureVision

2 (balafilcon A) Visibility Tinted Contact Lens

may be prescribed for Frequent/Planned Replacement or Disposable Wear.

leNs PARAMeTeRs AVAIlAble

The Bausch + Lomb PureVision

2 (balafilcon A) Visibility Tinted Contact Lens is a

hemispherical shell of the following dimensions:
Diameter: 14.0mm

Center Thickness:

0.05mm to 0.50mm

Base Curve:

8.6mm

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 PureVision

2 (balafilcon A) Visibility

Tinted Contact Lens when placed on the cornea acts as a refracting medium to

focus light rays on the retina. When placed on the cornea for therapeutic use,

the Bausch + Lomb PureVision

2 (balafilcon A) Visibility Tinted Contact Lens

acts as a bandage to protect the cornea and relieve pain during treatment of

ocular pathologies.

INdICATIONs

Vision Correction
The Bausch + Lomb PureVision

2 (balafilcon A) Visibility Tinted Contact

Lens is indicated for daily wear or extended wear from 1 to 30 days between

removals, for cleaning and disinfection or disposal of the lens, as recommended

by the eye care professional. The lens is indicated for the correction of refractive

ametropia (myopia and 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 +8.00D to -20.00D when prescribed for up to 30 days of extended wear

and from +20.00D to –20.00D for daily wear or extended wear up to 7 days.

Therapeutic Use
The Bausch + Lomb PureVision

2 (balafilcon A) Visibility Tinted Contact Lens

is also indicated for therapeutic use. Use as a bandage contact lens for corneal

protection and corneal pain relief during treatment of ocular pathologies as well

as post-surgical conditions. Applications of the Bausch + Lomb PureVision

(balafilcon A) Visibility Tinted Contact Lens include but are not limited to

conditions such as the following:
• For corneal protection in conditions such as entropion, trichiasis, tarsal

scars, recurrent corneal erosion and post surgical ptosis for corneal

protection;

• For corneal pain relief in conditions such as bullous keratopathy, epithelial

erosion and abrasion, filamentary keratitis, post-keratoplasty;

• For use as a bandage during the healing process of conditions such

as chronic epithelial defects, corneal ulcer, neurotrophic keratitis,

neuroparalytic keratitis, chemical burns, and post surgical epithelial

defects.

• For post-surgical conditions that include bandage use such as LASIK, PRK,

PK, PTK, lamellar grafts, corneal flaps, and additional corneal surgical

conditions.

Bausch + Lomb PureVision

2 (balafilcon A) Visibility Tinted Contact Lenses for

therapeutic use can also provide optical correction during healing if required.
Frequent/Planned Replacement Wear
When prescribed for Frequent/Planned Replacement Wear, the Bausch

+ Lomb PureVision

2 (balafilcon A) Visibility Tinted 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 PureVision

(balafilcon A) Visibility Tinted Contact Lens is to be discarded after each

removal.

CONTRAINdICATIONs

(ReAsONs NOT TO Use)

DO NOT USE the Bausch + Lomb PureVision

2 (balafilcon A) 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 PureVision

2 (balafilcon A) 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 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.

• 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.

Extended Wear
• The risk of microbial keratitis has been shown to be greater among users of

extended wear contact lenses than among users of daily wear contact lenses.

Some researchers believe that these complications are caused by one or

more of the following: a weakening of the cornea’s resistance to infections,

particularly during a closed-eye condition, as a result of hypoxia; an eye

environment which is somewhat more conducive to the growth of bacteria

and other microorganisms, particularly when a regular periodic lens removal

and disinfecting or disposal schedule has not been adhered to by the patient;

improper lens disinfection or cleaning by the patient; contamination of lens

care products; poor personal hygiene by the patient; patient unsuitability to the

particular lens or wearing schedule; accumulation of lens deposits; damage to

the lens; improper fitting; length of wearing time; and the presence of ocular

debris or environmental contaminants.

• While the great majority of patients successfully wear contact lenses, extended

wear of lenses also is reported to be associated with a higher incidence and

degree of epithelial microcycsts and infiltrates, and endothelial polymegathism,

which require consideration of discontinuation or restriction of extended wear.

The epithelial conditions are reversible upon discontinuation of extended wear.

The long term risk of microbial keratitis has not been determined for this lens.

Post-marketing studies are in progress.

The reversibility of endothelial effects of contact lens wear has not been

conclusively established. As a result, practitioners’ views of extended wearing

times vary from not prescribing extended wear at all to prescribing flexible

wearing times from occasional overnight wear to prescribing extended wearing

periods from 1 to 30 days with specified intervals of no lens wear for certain

patients, with follow-up visits, and with proper care regimen.

• 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 oxygen transmissibility is below the established threshold required to

prevent overnight corneal edema for the extremes of the power range, above

+3.00D and –5.00D.

In the U.S. clinical study, the rate of infiltrative keratitis was

found to be higher with higher lens powers (see Clinical Studies section of this

package insert).

• 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.

Holden BA, Mertz GW. Critical Oxygen Levels to Avoid Corneal Edema for Daily and Extended

Wear Contact Lenses. Invest Ophthalmol Vis Sci 25:1162, 1984.

• 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.

• Some patients will not be able to tolerate continuous wear even if able to

tolerate the same or another lens on a daily wear basis. Some patients who

are able to tolerate continuous wear will not be able to wear their lenses

continuously for 30 days. Patients should be carefully evaluated for continuous

wear prior to prescription and dispensing, and eye care professionals should

conduct early and frequent follow-up examination to determine ocular

response to continuous wear.

• 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 PureVision

(balafilcon A) Visibility Tinted Contact Lenses until the determination is made

that the eye has healed completely.

In Addition, For Therapeutic Use
• Close professional supervision is necessary for therapeutic use of

Bausch + Lomb PureVision

2 (balafilcon A) Visibility Tinted Contact Lenses.

• Medications necessary for treatment should be used with caution under close

supervision by the eye care professional.

Eye care professionals should carefully instruct patients about the following lens

care and safety precautions. For therapeutic use, in some circumstances only

the eye care professional will insert and remove lenses and if so, patients should

be instructed NOT to handle lenses themselves. It is strongly recommended

that patients be provided with a copy of the Bausch + Lomb PureVision

(balafilcon A) Visibility Tinted 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 Bausch +

Lomb

PureVision

2 (balafilcon A) Visibility Tinted 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.

• For THERAPEUTIC USE, in some circumstances only the eye care

professional will insert and remove lenses and if so, patients should be instructed

NOT to handle lenses themselves.

Solution Precautions

Do not use the Allergan Ultracare Disinfecting System or any of its

components (Ultracare Disinfecting Solution, Ultracare Neutralizing

Tablets, Lens Plus Daily Cleaner, and Ultrazyme Enzymatic Cleaner) to

clean and disinfect the Bausch + Lomb PureVision

2 (balafilcon A) Visibility

Tinted Contact Lens because the lens dimensions will be altered.
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.

• 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. The patient

should 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 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.
During THERAPEUTIC USE, an adverse effect may be due to the original

disease or injury or may be due to the effects of wearing a contact lens. There

is a possibility that the existing disease or condition might become worse when

a soft contact lens for therapeutic use is used to treat an already diseased or

damaged eye. The patient should be instructed to avoid serious eye damage by

contacting the eye care professional IMMEDIATELY if there is any increase in

symptoms while wearing the lens.