CONSTELLATION® Vision System with PUREPOINT® Laser
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 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.
Caution: Federal (USA) law restricts this device to sale
by, or on the order of, a physician.
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.
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.
Important Safety Information: Warnings and Cautions: A complete
listing is available in the CONSTELLATION® Vision System Operators
Manual. To obtain a copy, please contact Alcon Customer Service.
Attention: Reference the Directions for Use for a complete
listing of indications, warnings, and precautions.
Alcon® MIVS™ Portfolio
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.
Caution: Federal (USA) law restricts this device to sale
by, or on the order of, a physician.
Warnings and Precautions:
- 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: Reference the Directions for Use labeling for
a complete listing of indications, warnings, precautions, complications and adverse
events.
GRIESHABER® DSP Instrumentation
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.
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.
Caution: Federal (USA) law restricts this device to sale
by, or on the order of, a physician.
Warnings and Precautions: CONSTELLATION® Vision System
- 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 consumables supplied by Alcon 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 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.
Warnings and Precautions: GRIESHABER® DSP Instruments
- 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: Reference the device specific Directions for
Use for a complete listing of indications, warnings, and precautions.
GRIESHABER® DSP Aspheric Macular Lens
Indications for Use: The GRIESHABER® DSP
Aspheric Macular Lens is used to visualize the fundus and retinal structures during
vitreoretinal surgery. It is designed as a self-retaining contact lens to allow
hands-free operation.
Caution: Federal (USA) law restricts this device to sale
by, or on the order of, a physician.
Warnings and Precautions:
- The device may be used only by well trained physicians and personnel.
- Potential risk from reuse or reprocessing include: reduced optical quality,
surface damage on the optics, and foreign particle introduction to the eye.
- The surgeon’s team has to ensure that sufficient viscous fluid is available throughout
usage of the lens for continuous humidification of the cornea.
Attention: Reference the Directions for Use for a complete
listing of indications, warnings, and precautions.
Vitreoretinal Laser Probes
Indication: ALCON® Laser probes are fiber
optic probes indicated for use with an ALCON® Laser System. Each
package contains individually packaged sterile laser probes.
Caution: Federal (USA) law restricts this device to sale
by, or on the order of, a physician.
Warnings and Precautions:
- Do not use if package is damaged.
- Minimize the illuminator’s light intensity.
- Avoid operation of illuminated probes in air on consoles capable of illumination
levels and settings higher than 10 lumens. This can result in fiber deformation
and/or high surface temperatures.
Attention: Reference the Directions For Use for a complete
listing of indications, warnings specific to the laser model.
ALCON® Lighted Instruments with ENGAUGE® RFID
Caution: Federal (USA) law restricts this device to sale
by, or on the order of, a physician.
Caution: This document is not intended to substitute for
the necessity of reading and understanding the light source Operator’s Manual.
Indications and Usage: Fiber Optic Instruments with ENGAUGE®
Radio Frequency Identification Device (RFID) for use with the CONSTELLATION®
System. These instruments can be used on the ACCURUS® System or ACCURUS®
High Brightness Illuminator (AHBI) using the RFID Adapter Model Number 8065751140.
Warnings and Precautions:
- Minimize the light intensity and duration of exposure to the retina to
reduce risk of retinal photic injury.
- Avoid operation of a fiber in air on consoles capable of illumination levels and
settings higher than 10 lumens. This may result in fiber probe deformation and/or
high surface temperatures that may cause patient injury.
Attention: Reference the Directions for Use labeling for
a complete listing of indications, warnings, precautions, complications and adverse
events.