sofie

VISION CORRECTION USE

the

CONTACT LENS
DESCRIPTION: The SOFLENS" (polymacon) Contact Lens is a hemispherical flexible shell which covers cornea and may cover a portion of the adjacent sclera. It consists of 61.4% poly (2-hydroxyethyl methacrylate) and 38.6% water by weight when immersed in normal saline. The material has a refractive index of 1.43 and the lens has a visible light transmittance of more than 97%. ACTIONS: In its hydrated state a S0FLEN5" (polymacon) Contact Lens is soft and pliable. When placed on the human cornea, the hydrated SOFLENS* (polymacon) Contact Lens acts as a refracting medium to

(polymacon)

s*

lenses studied. The SOFLENS Carrying Case should be washed at least once a week with hot water and then rinsed thoroughly with distilled water. Soap or other cleaners should never be used to clean the carrying case. In order to remove protein deposits which may form on the lenses, wearers should use the SOFLENS Enzymatic Contact Lens Cleaning Tablets according to the directions for use which accompany the tablets. To prevent the formation of the protein deposits, patients should use the SOFLENS Enzymatic Contact Lens CleaningTablets once a week or as directed by the practitioner. Disinfecting with the SOFLENS* Aseptor" -Patient Unit is necessary to kill microorganisms. If a SOFLENS- Aseptor' is not available, the lenses may be disinfected by boiling them in their carrying case in a pan of water for 15 minutes. When this boiling method of disinfection is used, the lenses can be damaged if the boiling water is allowed to completely evaporate. The carrying case must always be tightly closed before disinfecting to prevent leakage of the saline from the case and subsequent dehydration of the lenses.
'

length of lens use and of no apparent clinical significance, were observed on approximately one-half of the

Fluorescein-Never use fluorescein while the patient is wearing the lenses because the lenses will become discolored. Whenever fluorescein is used, flush the eyes with sterile normal saline solution and wait at least one hour before replacing the lenses. Earlier replacement may cause the lenses to absorb residual

fluorescein,

compensate spherical ametropias.

INDICATIONS: SOFLENS" (polymacon) Contact Lenses are indicated for vision correction with non-diseased eyes and in aphakia.

use

in persons

ametropia and aphakia.

CONTRAINDICATIONS: SOFLENS* (polymacon) Contact Lenses are contraindicated in the presence of any active untreated infection or abnormality of the anterior segment of the eye with the exception of

WARNINGS: Abrasions and InfectionsIf a lens becomes less comfortable than it was when first placed on the wearer's cornea, the lens should be removed immediately and the wearer's eye and the lens examined for the possible presence of a foreign body. If any eye abrasion, ulcration, irritation or infection is present, or any abnormal eye condition is observed concurrent with lens wear, the lens should be removed

immediately and a physician consulted.

Infectious corneal ulcers have been reported, recommended procedures for care of the lenses.

usually associated with failure

to follow the

Aphakic PatientsAphaftic patients should not be fitted with SOFLENS" (polymacon) Contact Lenses during the postoperative period until, in the opinion of the surgeon, the eye has healed completely.
unable to place and remove the lenses should not be provided with them, failure to follow handling and sanitation instructions could lead to serious eye infections which might result in corneal ulcers. Malfunction and rusting of the metal interior of the Aseptor- -Patient Unit as well as discoloration and cracking of the lens case has been reported after varying periods of use. If such occurs, appropriate replacement is indicated to avoid interference with the disinfection procedure. Lens Sanitation and Handling-Persons who require only vision correction and who would not, or could not, adhere to the recommended daily sanitary care of SOFLENS* (polymacon) Contact Lenses or who are

ADVERSE REACTIONS: Serious corneal damage may result from wearing a SOFLENS* (polymacon) Contact Lens which has been soaked in a conventional contact lens solution. Eye irritation may occur within a short time after putting on a hypertonic lens. Removal of the lens will relieve the irritation. A lens adheres very rarely to an eye as a result of sleeping with the lens on, or wearing a hypotonie lens. If a lens adheres for any reason, apply normal saline and wait until the lens moves freely before removing it. Clinical studies indicate that corneal edema, as manifested by symptoms such as rainbows, halos around lights, or foggy vision, may occur in less than 5% of SOFLENS*" (polymacon) Contact Lens wearers. If these symptoms occur, the lenses should be removed and professional consultation obtained. Excessive tearing, unusual eye secretions, and photophobia are not normal. If these symptoms occur, the patient should be examined to determine their cause. A faint blue haze, believed to be located in Descemet's membrane, has been reported in the Spokane, Washington area. As yet, the cause is unknown and the phenomenon has not been found elsewhere. The wearers report no subjective symptoms and there is no detectable effect on their visual acuity. There have been approximately 29 cases, and in 10 of these patients the blue haze has cleared or is in various stages of regression. Neovascularization of the cornea has been observed in some aphakic patients fitted with the SOFLENS" (polymacon) Contact Lens, which may require discontinuation of the lens. Medical consultation should be obtained in such an instance. LENS REPLACEMENT: Various studies have been conducted to determine the frequency of lens replacements and the reasons for those replacements. These studies show that during the first four months of wear, approximately one quarter of the lenses initially dispensed are replaced; the principal reason for these replacements is lens damage. Lenses are more apt to be damaged while new wearers are learning the prescribed handling and care techniques. After the initial four months of wear, the average tens replacement rate has been found to be approximately one lens per wearer per year. Lens loss, damage and surface deposits were the major causes for lens replacements.

Medicante and Eye Drops-When the lenses are used by persons requiring only vision correction no ophthalmic solutions or medicants, including conventional contact lens solutions and eye drops, should be used by SOFLENS (polymacon) Contact Lens wearers prior to placement, or while the lens is in place, on the eye. Also, no solutions, including conventional contact lens solutions other than normal saline, and the solution made from the SOFLENS Enzymatic Contact Lens Cleaning Tablets are to be used on a
"

SOFLENS* (polymacon) Contact Lens when the lens is off the eye.

Wearing RestrictionsSOFLENS' (polymacon) Contact Lenses when used only for vision correc tion should be removed before sleeping or swimming and in the presence of noxious and irritating vapors. Safety in pregnancy has not been substantiated. Insufficient lacrimal secretions or hypoesthesia may be
restricting factors to the wearing of soft contact lenses.
'

Incorporated, Rochester, N.Y. 14602. When the lenses are used only for vision correction, there may be a tendency for the patient to overwear the lenses initially. Therefore, the importance of adhering to the following initial daily wearing schedule should be stressed to these patients:
Wear
Time

DOSAGE AND ADMINISTRATION: Conventional methods of fitting contact lenses do not apply to SOFLENS* (polymacon) Contact Lenses. For a detailed description of the fitting technique, refer to the SOFLENS Fitting Guide, copies of which are available from: SOFLENS Division, Bausch & Lomb

PRECAUTIONS: Storage SOFLENS (polymacon) Contact Lenses must be stored ONLY in normal saline solution. If left exposed to air, the lenses will dehydrate, become brittle, and break readily. If a lens dehydrates, it should be resoaked in normal saline solution until it returns to its soft, pliable state which Fresh normal saline must be prepared daily for cleaning and storing the lenses. The carrying case must be emptied and refilled with fresh normal saline solution just before disinfecting the lenses. The one ounce squeeze bottle is intended for preparation of normal saline only. As this saline is not aseptic, it should not be used to clean a lens that is to be replaced immediately on the eye, nor should this solution ever be placed in the eye. If the patient wishes to remove a lens, clean it, or wet it and replace it on the eye, the solution in the carrying case should be used, as it will have been disinfected.
may take as

long as forty minutes.

Hygiene-Hands must be washed, rinsed thoroughly, and dried with a lint-free towel before handling the
Cosmetics, lotions, soaps, and creams must not come in contact with the lenses since eye irritation may result. If hair spray is used while the lenses are being worn, the eyes must be kept closed until the hair spray has settled.
lenses.

13 13 13 13 13 3 14 14 4 14 4 14 4 16 14 5 6 16 14 6 6 18 7 8 8 8 18 9 8 18 balance of the waking hours* 10 10 1 11 12 1 balance of the waking hours* balance of the waking hours* 12 14 1 "Lenses used only for vision correction should never be worn 24 hours a day. When lenses are dispensed for vision correction, the wearer must be supplied with a lens care kit and must fully understand all lens care and handling instructions. As with any contact lens, regular recall visits are necessary to assure corneal health and wearer compliance with instructions. 2 3
HOW SUPPLIED: Each lens is supplied sterile in a glass vial containing sterile normal saline solution. The glass vial is marked with the manufacturing lot number of the lens and the dioptric power (black lor plus power lenses; red for minus; gold for piano). Caution: Federal Law Prohibits Dispensing Without a Prescription. The SOFLENS- Care Kit is available for lens disinfecting, cleaning, and storage, consisting of the Cat. # 140307 Cat. #140302

Day

(hours)

(hours)

Rest Period

Wear
Time

(hours)

(hours)

Rest Period

(hours)

Time

Wear

HandlingA SOFLENS* (polymacon) Contact Lens may be damaged by nicking or tearing if care is not exercised during placement on or removal from the eye, replacing or removing it from the carrying case or in the cleaning process. Lenses must be placed very carefully in the carrying case to avoid damaging the edges of the lenses.
the lens' surface. The carrying case must be emptied and refilled with fresh normal saline solution just before disinfecting the lenses The causes and nature of deposits formed on the surfaces of some lenses have not been completely evaluated. However, some coatings are known to be proteinaceous and others may be oily or greasy film from extraneous agents, such as hair spray or other cosmetics, or from the patient's own lacrimal secretions. Many wearers experience little or no difficulty with such deposits. However, occasionally a wearer, who tends to secrete unusually large arhounts of mucus in the lacrimal fluid, may experience a build-up of these deposits within a relatively few weeks, despite adequate cleaning measures. If surface accumulations of nonremovable materials persist, professional care should be obtained promptly. Deposits, characterized as medium or heavy, were found on 17.5 percent of a population of lenses worn an average of 11.2 months, including lenses worn as long as thirty months. The occurrence of these deposits appeared to increase with the duration of lens use. These medium or heavy deposits, when they do exist, can be detected by means of a slit lamp biomicroscope examination. Light deposits, unrelated to

(polymacon) Contact Lens must be irrigated with saline and rubbed gently to remove mucus and film from
"

Disinfecting-Fresh

normal saline must be

prepared daily. After removal from the

eye, the SOFLENS

following;

SOFLENS Enzymatic Contact Lens Cleaning Tablets

SOFLENS" Squeeze Bottle SOFLENS" Salt Tablets SOFLENS" Patient Instruction Book

LENSGARDTM Carrying Case SOFLENS" Aseptor* Patient Unit

Cat. #140304 Cat. #140305 Cat. #140300-100

are

Cat. #140310

SOFLENS Enzymatic Contact Lens

packages of:

Cleaning Tablets
Cat. #140395 Cat. # 140396

also

supplied

in refill

24 Tablets 48 Tablets

FEBRUARY 1976

BAUSCH & LOMB

Rochester.N.Y. 14602

October 1976

SL 1304

Printed in U.S.A.

SOFLENS DIVISION

)
w