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Important Safety Information for Gas Permeable and Customized Soft Contact Lenses

WARNINGS:

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 practitioner’s directions 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.
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 practitioner.

CONTRAINDICATIONS:

Do not use when any of the following conditions exist:

Acute or subacute inflammation or infection of the anterior chamber of the eye
Any eye disease, injury or abnormality, other than keratoconus, PMD, that affects the cornea, conjunctiva, or eyelids
Severe insufficiency of lacrimal secretion (dry eye)
Corneal hypoesthesia (reduced sensitivity), if not aphakic
Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses
Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or using contact lens solutions
Allergy to any ingredient in a solution which is to be used to care for contact lenses
Any active corneal infection (bacterial, fungal, or viral)
Red or irritated eyes

ADVERSE EFFECTS:

The following problems may occur with the use of contact lenses:

Eyes stinging, burning, itching, irritation or other eye pain
Comfort is less than when the lens was first placed on the eye
Feeling of something in the eye such as a foreign body, scratched area
Excessive watering (tearing) of the eye
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

Important Safety Information for OrthoKeratology Lenses

INDICATIONS FOR USE

Boston^® Orthokeratology (oprifocon A) shaping lenses for overnight wear are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear as part of the Bausch + Lomb Vision Shaping Treatment VST^® process for the temporary reduction of myopia up to 5.00 diopters with eyes having astigmatism up to 1.50 diopters. The lenses may only be disinfected using a chemical disinfection system.

SAFETY INFORMATION

CONTRAINDICATIONS

DO NOT USE the Boston Orthokeratology (oprifocon A) shaping lenses when any of the following conditions exist:

Acute and sub-acute inflammations 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 tears (dry eyes)
Corneal hypoesthesia (reduced corneal sensitivity)
Any systemic disease which may affect the eye or be exacerbated by wearing contact lenses
Allergic reactions of ocular surfaces or adnexa which 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 your Boston Orthokeratology (oprifocon A) shaping lenses
Any active corneal infection (bacterial, fungal, or viral)
If eyes become red or irritated

WARNINGS

The risk of ulcerative keratitis has been shown to be greater among wearers of extended wear lenses than among wearers of daily wear lenses. The risk among extended wear use users increases the number of consecutive days that lenses are worn between removals, beginning with the first overnight use. This risk can be reduced by carefully following directions for routine lens care, including cleaning the storage case. Additionally, smoking increases the risk of ulcerative keratitis for contact lens wearers. It is recommended that contact lens wearers see their eye care practitioners twice each year, or if directed, more frequently.

Orthokeratology lenses are to be worn overnight with removal during all or part of each following day. Wearing the lenses continuously (extended wear) presents increased risk, which increases with the number of consecutive days the lenses are worn between removals. Although the safety risks of overnight wear with removal upon wakening may not be as great as with extended wear, there is still increased risk beginning with the first overnight period.

PRECAUTIONS

When selecting an appropriate lens design and parameters, the eye care practitioner should consider all factors that affect lens performance and the patient’s ocular health; including oxygen permeability, wettability, central and peripheral thickness, and optic zone diameter.

Patients should be cautioned to limit the wearing schedule by their eye care practitioner regardless of how comfortable the lenses feel.

The safety and effectiveness of the Boston Orthokeratology (oprifocon A) shaping lenses have not been clinically studies in adolescent and pediatric subjects. The potential impact of these factors should be weighed against the patient’s need for refractive reduction; therefore, the continuing ocular health of the patient, and lens performance on the eye should be carefully monitored by the prescribing eye care practitioner.

Boston Orthokeratology (oprifocon A) shaping lenses are supplied non-sterile in an individual plastic case. The lens is shipped dry and must be cleaned and conditioned prior to use.

ADVERSE EVENTS

A total of 378 eyes (191 patients) were enrolled in the clinical study. There were twelve significant lens-related adverse events reported in ten subjects. Two eyes had bilateral grade 4 staining with significant decrease in vision to 20/80. One eye had grade 3 corneal staining secondary to a dislodged lens. One eye had significant corneal distortion with reduced vision to 20/200 and rippling on the cornea. Two eyes had bilateral iritis with trace cells and flare in both eyes. One eye had corneal infiltrates. Two eyes had abrasions (grade 3 staining). One eye had reduction of BSCVA to 20/50 secondary to a decentered lens. One eye had reduction of BSCVA to 20/60 due to central staining. One eye had reduction of BSCVA to 20/60 with no reason given.

All eyes that showed acuity reductions were documented as returning to normal vision, except two eyes of one subject with severe corneal staining that showed ≥2 lines loss of BSCVA. The return to pre-treatment VA was not recorded for this subject, although the subject returned to soft contact lens wear and verbally reported that vision was normal. All adverse events resolved without further complications.

ATTENTION: Refer to the package insert for a complete listing of indications, warnings and precautions, clinical trial information, etc.

CAUTION: Federal (USA) law restricts this device to the sale by, or on the order of a licensed practitioner.