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:
The FlexTip* laser probe is intended to be used with ALCON® 532nm laser systems.
Contraindications:
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:
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
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.
Warnings and Precautions:
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:
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:
Attention: Please refer to the product labeling for a complete listing of indications, warnings, and precautions.
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.
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:
WARNINGS/PRECAUTIONS:
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.
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:
WARNINGS/PRECAUTIONS:
ATTENTION: Refer to the Directions for Use for a complete listing of indications, warnings, precautions, complications and adverse events.
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