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Vitreoretinal Procedures

Intraocular Irrigating Solution

In a recent study, it has been shown that when oxidized glutathione (GSSG) in BSS PLUS® Irrigating Solution is used for vitrectomy, the GSSG is converted to reduced glutathione (GSH) in the retina. The glutathione from BSS PLUS® Irrigating Solution ultimately is incorporated into the intracellular glutathione pool.1

Additionally, it has been shown that BSS PLUS® Irrigating Solution is less harmful than GSSG-free solutions to the barrier function of the RPE cells, and the GSSG has a beneficial effect in maintaining the functions of the RPE.2

Diabetic retinopathy results when abnormal changes take place in the blood vessels of the retina. In many patients, retinal blood vessels may swell and hemorrhage, where in others abnormal new blood vessels grow on the surface of the retina. BSS PLUS® Irrigating Solution has been shown to help fight the oxidative effects of free-radical formation during surgery. Recent studies have shown that the retina and choroid can benefit from supplemental glutathione found in BSS PLUS® Irrigating Solution.3

Restoration of normal vision, or the prevention of continued visual loss, can now be accomplished in more advanced or difficult vitreoretinal conditions. Macular holes and proliferative vitreoretinopathy are common and visually debilitating conditions.

In proliferative vitreoretinopathy, the retina develops fixed folds secondary to the formation of taut vitreal and pre-retinal fibrous membranes. This severe distortion of the retina often results in a complicated retinal detachment. In macular hole conditions, the retina develops a hole in the macular region. These disease states are accompanied by dramatic visual loss and lengthy, complicated surgeries. BSS PLUS® Irrigating Solution protects the ocular tissues that have been exposed to the atmosphere, microscope light and metabolic stress from free-radical formation.

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Important information about BSS PLUS® Irrigating Solution

Description: BSS PLUS® a sterile intraocular irrigating solution is used during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extracapsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery.

Indications and Usage: BSS PLUS® Irrigating Solution is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.

Contraindications: There are no specific contraindications to the use of BSS PLUS® Irrigating Solution; however, contraindications for the surgical procedure during which BSS PLUS® Irrigating Solution is to be used should be strictly adhered to.

Warnings: For IRRIGATION during ophthalmic surgery only. Not for injection or intravenous infusion. Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged. Do not use if product is discolored or contains a precipitate.

Precautions: DO NOT USE BSS PLUS® IRRIGATING SOLUTION UNTIL PART I IS FULLY RECONSTITUTED WITH PART II. Discard unused contents. BSS PLUS® Irrigating Solution does not contain a preservative; therefore, do not use this container for more than one patient. Do not use additives other than BSS PLUS® Irrigating Solution Concentrate Part II (20 mL) with this product. Tissue damage could result if other drugs are added to product. DISCARD ANY UNUSED PORTION SIX HOURS AFTER PREPARATION. Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed. There have been reports of corneal clouding or edema following ocular surgery in which BSS PLUS® Irrigating Solution was used as an irrigating solution. As in all surgical procedures appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions: Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the use of BSS PLUS® Irrigating Solution has not been established.

Overdosage: The solution has no pharmacological action and thus no potential for overdosage. However, as with any intraocular surgical procedure, the duration of intraocular manipulation should be kept to a minimum.

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BSS PLUS® Irrigating Solution
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Important information about BSS PLUS® Irrigating Solution

Description: BSS PLUS® a sterile intraocular irrigating solution is used during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extracapsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery.

Indications and Usage: BSS PLUS® Irrigating Solution is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.

Contraindications: There are no specific contraindications to the use of BSS PLUS® Irrigating Solution; however, contraindications for the surgical procedure during which BSS PLUS® Irrigating Solution is to be used should be strictly adhered to.

Warnings: For IRRIGATION during ophthalmic surgery only. Not for injection or intravenous infusion. Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged. Do not use if product is discolored or contains a precipitate.

Precautions: DO NOT USE BSS PLUS® IRRIGATING SOLUTION UNTIL PART I IS FULLY RECONSTITUTED WITH PART II. Discard unused contents. BSS PLUS® Irrigating Solution does not contain a preservative; therefore, do not use this container for more than one patient. Do not use additives other than BSS PLUS® Irrigating Solution Concentrate Part II (20 mL) with this product. Tissue damage could result if other drugs are added to product. DISCARD ANY UNUSED PORTION SIX HOURS AFTER PREPARATION. Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed. There have been reports of corneal clouding or edema following ocular surgery in which BSS PLUS® Irrigating Solution was used as an irrigating solution. As in all surgical procedures appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions: Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the use of BSS PLUS® Irrigating Solution has not been established.

Overdosage: The solution has no pharmacological action and thus no potential for overdosage. However, as with any intraocular surgical procedure, the duration of intraocular manipulation should be kept to a minimum.

Important information about DuoVisc® OVD

Description: DuoVisc® Viscoelastic System is designed to give two Viscoelastic materials with different physico-chemical properties that can be used differently and/or sequentially to perform specific tasks during a cataract procedure. DuoVisc® Viscoelastic System consists of VISCOAT® Ophthalmic Viscosurgical Device and ProVisc® Ophthalmic Viscosurgical Device.

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

Description: VISCOAT® (Sodium Chondroitin Sulfate – Sodium Hyaluronate) Ophthalmic Viscosurgical Device

Indications: VISCOAT® OVD is indicated for use as an ophthalmic surgical aid in anterior segment procedures including cataract extraction and intraocular lens (IOL) implantation. VISCOAT® OVD maintains a deep anterior chamber during anterior segment surgeries, enhances visualization during the surgical procedure, and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery.

Warnings: Failure to follow assembly instructions or use of an alternate cannula may result in cannula detachment and potential patient injury.

Precautions: Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material.

Adverse Reactions: VISCOAT® OVD has been extremely well tolerated in human and animal studies. A transient rise in intraocular pressure in the early postoperative period may be expected due to the presence of sodium hyaluronate, which has been shown to effect such a rise. It is therefore recommended that VISCOAT® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber.

ATTENTION: Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions.

Important information about BSS PLUS® Irrigating Solution

Description: BSS PLUS® a sterile intraocular irrigating solution is used during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time (e.g., pars plana vitrectomy, phacoemulsification, extracapsular cataract extraction/lens aspiration, anterior segment reconstruction, etc.). The solution does not contain a preservative and should be prepared just prior to use in surgery.

Indications and Usage: BSS PLUS® Irrigating Solution is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.

Contraindications: There are no specific contraindications to the use of BSS PLUS® Irrigating Solution; however, contraindications for the surgical procedure during which BSS PLUS® Irrigating Solution is to be used should be strictly adhered to.

Warnings: For IRRIGATION during ophthalmic surgery only. Not for injection or intravenous infusion. Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged. Do not use if product is discolored or contains a precipitate.

Precautions: DO NOT USE BSS PLUS® IRRIGATING SOLUTION UNTIL PART I IS FULLY RECONSTITUTED WITH PART II. Discard unused contents. BSS PLUS® Irrigating Solution does not contain a preservative; therefore, do not use this container for more than one patient. Do not use additives other than BSS PLUS® Irrigating Solution Concentrate Part II (20 mL) with this product. Tissue damage could result if other drugs are added to product. DISCARD ANY UNUSED PORTION SIX HOURS AFTER PREPARATION. Studies suggest that intraocular irrigating solutions which are iso-osmotic with normal aqueous fluids should be used with caution in diabetic patients undergoing vitrectomy since intraoperative lens changes have been observed. There have been reports of corneal clouding or edema following ocular surgery in which BSS PLUS® Irrigating Solution was used as an irrigating solution. As in all surgical procedures appropriate measures should be taken to minimize trauma to the cornea and other ocular tissues.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions: Postoperative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the use of BSS PLUS® Irrigating Solution has not been established.

Overdosage: The solution has no pharmacological action and thus no potential for overdosage. However, as with any intraocular surgical procedure, the duration of intraocular manipulation should be kept to a minimum.

Important information about DuoVisc® OVD

Description: DuoVisc® Viscoelastic System is designed to give two Viscoelastic materials with different physico-chemical properties that can be used differently and/or sequentially to perform specific tasks during a cataract procedure. DuoVisc® Viscoelastic System consists of VISCOAT® Ophthalmic Viscosurgical Device and ProVisc® Ophthalmic Viscosurgical Device.

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

Description: VISCOAT® (Sodium Chondroitin Sulfate – Sodium Hyaluronate) Ophthalmic Viscosurgical Device

Indications: VISCOAT® OVD is indicated for use as an ophthalmic surgical aid in anterior segment procedures including cataract extraction and intraocular lens (IOL) implantation. VISCOAT® OVD maintains a deep anterior chamber during anterior segment surgeries, enhances visualization during the surgical procedure, and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery.

Warnings: Failure to follow assembly instructions or use of an alternate cannula may result in cannula detachment and potential patient injury.

Precautions: Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material.

Adverse Reactions: VISCOAT® OVD has been extremely well tolerated in human and animal studies. A transient rise in intraocular pressure in the early postoperative period may be expected due to the presence of sodium hyaluronate, which has been shown to effect such a rise. It is therefore recommended that VISCOAT® OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of surgery to minimize postoperative IOP increases. Do not overfill anterior chamber.

ATTENTION: Reference the Physician Labeling/Directions for Use for a complete listing of indications, warnings and precautions.