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AcrySof® IQ +

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Perfluoron® +

CONSTELLATION^® System with PUREPOINT^® Laser Brief Statement

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

Indications for Use: The CONSTELLATION^® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery.

The ULTRAVIT^® Vitrectomy Probe is indicated for vitreous cutting and aspiration, membrane cutting and aspiration, dissection of tissue and lens removal. The valved entry system is indicated for scleral incision, canulae for posterior instrument access and venting of valved cannulae. The infusion cannula is indicated for posterior segment infusion of liquid or gas.

The PUREPOINT^® Laser is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:

Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); choroidal neovascularization secondary to age-related macular degeneration; retinal tears and detachments; macular edema, retinopathy of prematurity; choroidal neovascularization; leaking microaneurysms.
Iridotomy/Iridectomy for treatment of chronic/primary open angle glaucoma, acute angle closure glaucoma and refractory glaucoma.
Trabeculoplasty for treatment of chronic/primary open angle glaucoma and refractory glaucoma.
And other laser treatments including: internal sclerostomy; lattice degeneration; central and branch retinal vein occlusion; suturelysis; vascular and pigment skin lesions.

The FlexTip* laser probe is intended to be used with ALCON^® 532nm laser systems.

Contraindications:

Patients with a condition that prevents visualization of target tissue (cloudy cornea, or extreme haze of the aqueous humor of the anterior chamber of vitreous humor) are poor candidates for LIO delivered laser treatments.
The infusion cannula is contraindicated for use of oil infusion.

Complications: Corneal burns, inflammation, loss of best-corrected visual acuity, loss of visual field and transient elevations in intraocular pressure can occur as a result of ophthalmic laser treatment. Unintentional retinal burns can occur if excessive treatment beam power or duration is used.

Warnings and Precautions:

The disposables used in conjunction with ALCON^® instrument products constitute a complete surgical system. Use of disposables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.
Attach only Alcon supplied consumables to console and cassette luer fittings. Do not connect consumables to the patient's intravenous connections.
Mismatch of consumable components and use of settings not specifically adjusted for a particular combination of consumable components may create a patient hazard.
Vitreous traction has been known to create retinal tears and retinal detachments.
The closed loop system of the CONSTELLATION^® Vision System that adjusts IOP cannot replace the standard of care in judging IOP intraoperatively. If the surgeon believes that the IOP is not responding to the system settings and is dangerously high or low, this may represent a system failure. Note: To ensure proper IOP Compensation calibration, place infusion tubing and infusion cannula on a sterile draped tray at mid-cassette level during the priming cycle.
Leaking sclerotomy may lead to post operative hypotony.
Back scattered radiation is of low intensity and is not harmful when viewed through a protective filter. All personnel in the treatment room must wear protective eyewear, OD4 or above at 532nm, when the system is in Standby/Ready mode as well as during treatment. The doctor protection filter is an OD greater than 4 at 532nm.

Attention: Please refer to the CONSTELLATION^® Vision System Operators Manual for a complete listing of indications, warnings, and precautions.

*Trademarks are property of their respective owners.

CON12290PI

MIVS Brief Statement

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

Warnings and Precautions:

The infusion cannula is contraindicated for use of oil infusion.
Attach only Alcon supplied products to console and cassette luer fittings. Improper usage or assembly could result in a potentially hazardous condition for the patient. Mismatch of surgical components and use of settings not specifically adjusted for a particular combination of surgical components may affect system performance and create a patient hazard. Do not connect surgical components to the patient's intravenous connections.
Each surgical equipment/component combination may require specific surgical setting adjustments. Ensure that appropriate system settings are used with each product combination. Prior to initial use, contact your Alcon sales representative for in-service information.
Care should be taken when inserting sharp instruments through the valve of the Valved Trocar Cannula. Cutting instrument such as vitreous cutters should not be actuated during insertion or removal to avoid cutting the valve membrane. Use the Valved Cannula Vent to vent fluids or gases as needed during injection of viscous oils or heavy liquids.
Visually confirm that adequate air and liquid infusion flow occurs prior to attachment of infusion cannula to the eye.
Ensure proper placement of trocar cannulas to prevent sub-retinal infusion.
Leaking sclerotomies may lead to post operative hypotony.
Vitreous traction has been known to create retinal tears and retinal detachments.
Minimize light intensity and duration of exposure to the retina to reduce the risk of retinal photic injury.

ATTENTION: Please refer to the CONSTELLATION^® Vision System Operators Manual for a complete listing of indications, warnings and precautions.

GAU12239PI

Indications for Use: The Finesse™ Flex Loop is a manual ophthalmic surgical instrument intended to aid in ophthalmic surgical procedures. The device may be used in posterior segment surgery to create an edge on a membrane to begin peeling with forceps. The device is provided sterile and is intended for single use.

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

Warning and Precautions:

It is not recommended to remove the ILM (internal limiting membrane) with the device. Scraping the retina can cause irreversible damage to the nerve fibers.
Inspect tip for damage (e.g. burrs, bending or loosening), check loop functionality (extendability), and ensure the loop is fully retracted before inserting instrument into the eye.

Attention: Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

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

Indications for Use: GRIESHABER^® DSP instruments are a line of single-use vitreoretinal micro-instruments which are used in ophthalmic surgery, for cases either in the anterior or the posterior segment. The GRIESHABER^® Advanced Backflush Handles DSP are a family of instruments for fluid and gas handling in vitreoretinal surgery.

Warnings and Precautions:

Potential risk from reuse or reprocessing GRIESHABER^® DSP instruments include: foreign particle introduction to the eye; reduced cutting or grasping performance; path leaks or obstruction resulting in reduced fluidics performance.
Verify correct tip attachment, function and tip actuation before placing it into the eye for surgery.
For light fiber instruments: Minimize light intensity and duration of exposure to the retina to reduce risk of retinal photic injury. The light fiber instruments are designed for use with an ALCON^® illumination source.
Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. If stream of fluid is weak or absent, good fluidics response will be jeopardized.
Use appropriate pressure supply to ensure a stable IOP.
If unwanted tissue gets engaged to the aspiration port, it should be released by interrupting aspiration before moving the instrument.

Attention: Please refer to the product labeling for a complete listing of indications, warnings, and precautions.

AcrySof^® IQ Intraocular Lenses – Physician Brief Statement

CAUTION:

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

INDICATIONS:

The AcrySof^® IQ posterior chamber intraocular lens is intended for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag.

WARNING/PRECAUTION:

Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Caution should be used prior to lens encapsulation to avoid lens decentrations or dislocations.

Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof^® Natural IOL and normal color vision. The effect on vision of the AcrySof^® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS^® or BSS PLUS^® Sterile Intraocular Irrigating Solutions.

ATTENTION:

Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions.

Important Safety Information for SILIKON™ 1000 Oil Brief Statement

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

INDICATION: SILIKON™ 1000 oil is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perforating injuries. SILIKON™ 1000 oil is also indicated for primary use in detachments due to Acquired Immune Deficiency Syndrome (AIDS), related CMV retinitis and other viral infections affecting the retina.

CONTRAINDICATIONS:

SILIKON™ 1000 oil (purified polydimethylsiloxane) is contraindicated in patients with known hypersensitivity to silicone oil.
SILIKON™ 1000 oil is contraindicated in pseudophakic patients with silicone intraocular lenses.

WARNINGS/PRECAUTIONS:

Oil-induced pupillary block and angle closure can occur in aphakic eyes if a six o’clock iridectomy is not performed.
Do not use a vial for more than one patient.
Discard unused portion.
Do not admix with any other substances prior to injection.
Do not resterilize.
Do not use expired product.
An underfill may result in an ineffective inferior tamponade and an overfill may result in corneal abnormalities and elevated IOP.
The use of SILIKON™ 1000 oil as a long term tamponade has not been studied and must be determined by the treating physician. SILIKON™ 1000 oil should be removed when, in the judgment of the physician, the retinal attachment would not be compromised.

Caution must be exercised when using CO2 laser in patients with a history of intraocular silicone oil placement.

ATTENTION: Refer to the Directions for Use for a complete listing of indications, warnings, precautions, complications and adverse events.

Important Product Information for PERFLUORON^® Liquid

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

INDICATION: PERFLUORON^® (purified perfluoro-n-octane liquid) is an intraoperative tool indicated for use during vitreoretinal surgery in patients with primary or recurrent retinal detachment which is complicated by penetrating ocular trauma, giant retinal tear(s) or proliferative vitreoretinopathy (PVR).

CONTRAINDICATIONS:

PERFLUORON^® liquid is contraindicated for long-term use in the eye or as a vitreous replacement.

WARNINGS/PRECAUTIONS:

PERFLUORON^® liquid should not be injected directly into the vitreous, or injected simultaneously with aspiration of the vitreous, as severe intraocular damage may occur.
At the conclusion of the surgical procedure PERFLUORON^® liquid must be COMPLETELY removed from the eye and replaced with an appropriate vitreous substitute.
Subretinal migration or placement of PERFLUORON^® (purified perfluoro-n-octane liquid) may occur during the injection of the device (See Directions for Use).

ATTENTION: Refer to the Directions for Use for a complete listing of indications, warnings, precautions, complications and adverse events.

About The Inside View

CONSTELLATION® System with PUREPOINT® Laser Brief Statement

MIVS Brief Statement

AcrySof® IQ Intraocular Lenses – Physician Brief Statement

Important Safety Information for SILIKON™ 1000 Oil Brief Statement

Important Product Information for PERFLUORON® Liquid

CONSTELLATION^® System with PUREPOINT^® Laser Brief Statement

AcrySof^® IQ Intraocular Lenses – Physician Brief Statement

Important Product Information for PERFLUORON^® Liquid