OCUCOAT is a sterile, isotonic, nonpyrogenic viscoelastic solution of highly purified, noninflammatory, 2% hydroxypropylmethylcellulose with a high molecular weight greater than 80,000 daltons. OCUCOAT is supplied in 1 mL syringes. Each mL provides 20 mg/mL of hydroxypropylmethylcellulose dissolved in a physiological balanced salt solution containing 0.49% sodium chloride, 0.075% potassium chloride, 0.048% calcium chloride, 0.03% magnesium chloride, 0.39% sodium acetate, 0.17% sodium citrate and water for injection. The osmolarity of OCUCOAT is 285 ± 32 mOsM, the viscosity is 4000 ± 1500 cst, and the pH is 7.2±0.4.

Characteristics:   OCUCOAT is an ophthalmic surgical aid for use in anterior segment surgery.

OCUCOAT:

1. Is a space occupying, tissue protective substance
2. Exhibits excellent flow properties
3. Is completely transparent
4. Is nonantigenic
5. Is easily removed from the anterior chamber
6. Contains no proteins which may cause inflammation or foreign body reactions
7. Requires no refrigeration or restrictive storage conditions
8. Does not interfere with normal wound healing process
9. Clears the trabecular meshwork in 24 hours (98% clearance rate)

OCUCOAT is indicated for use as an ophthalmic surgical aid in anterior segment surgical procedures, including cataract extraction and intraocular lens implantation. OCUCOAT maintains a deep chamber during anterior segment surgery and thereby allows for more efficient manipulation with less trauma to the corneal endothelium and other ocular tissues. The viscoelasticity of OCUCOAT helps the vitreous face to be pushed back, thus preventing formation of a postoperative flat chamber.

Clinical Applications:   In anterior segment surgery, OCUCOAT should be carefully introduced into the anterior chamber using a 20 gauge or smaller cannula. OCUCOAT may be injected into the chamber prior to or following delivery of the crystalline lens. Injection of OCUCOAT prior to lens delivery will provide additional protection to the corneal endothelium and other ocular tissues. Injection of the material at this point is significant in that a coating of OCUCOAT may protect the corneal endothelium from possible damage arising from surgical instrumentation during the cataract extraction surgery.

OCUCOAT may also be used to coat an intraocular lens as well as tips of surgical instruments prior to implantation surgery. Additional OCUCOAT may be injected during anterior segment surgery to fully maintain the chamber or to replace fluid lost during the surgical procedure. OCUCOAT should be removed from the anterior chamber at the end of surgery. Rather than aspirate OCUCOAT from the eye with the OCUCOAT syringe, it is recommended that OCUCOAT be aspirated using an automated I/A device, or irrigated using an irrigation syringe or a BSS squeeze bottle.

OCUCOAT is a sterile, nonpyrogenic, viscoelastic preparation supplied in a 1 mL single use glass syringe with a Luer tip and a Luer lock cannula. OCUCOAT syringes are aseptically packaged and terminally sterilized. The sterility expiration date is on the outer package.

Store at room temperature; avoid excessive heat (60° C). Protect from light. For intraocular use.

Warning: Manufactured with CFC-12, a substance which harms public health and environment by destroying ozone in the upper atmosphere.

Caution:  Federal (USA) law restricts this device to sale by or on the order of a physician. For intraocular use only. Discard unused contents of OCUCOAT syringe after each use. Do not resterilize.

Contact your local representative or Bausch & Lomb Surgical directly at 1 (800) 338-2020 or (909) 624-2020.

Clinical testing of OCUCOAT showed it to be extremely well tolerated after injection into the human eye.

A transient rise in intraocular pressure postoperatively has been reported in some cases.

Rarely, postoperative inflammatory reactions (iritis, hypopyon), as well as incidents of corneal edema and corneal decompensation, have been reported with viscoelastic agents. Their relationship to OCUCOAT has not been established.

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Manufactured with CFC-12, a substance which harms public health and environment by destroying ozone in the upper atmosphere.

Precautions are limited to those normally associated with the ophthalmic surgical procedure being performed.

There may be transient increased intraocular pressure following surgery because of pre-existing glaucoma or due to the surgery itself. For these reasons, the following precautions should be considered:

• OCUCOAT should be removed from the anterior chamber at the end of surgery.
• If the postoperative intraocular pressure increases above expected values, appropriate therapy should be administered.

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At present, there are no known contraindications to the use of OCUCOAT when used as recommended.

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