Alcon, the global leader in eye care, provides innovative products that enhance quality of life by helping people worldwide see better. Alcon’s three businesses, Surgical, Pharmaceutical and Vision Care, offer the widest spectrum of eye care products in the world. Alcon is the second largest division of the Novartis Group, with pro-forma sales of USD 10.8 billion in 2014.

Headquartered in Fort Worth, Texas, USA, Alcon has more than 25,000 employees worldwide, operations in 75 countries and products available in 180 markets.

Elizabeth Harness Murphy
Alcon Global Communications
817.551.8696 (office)
585.435.7379 (mobile)
[email protected]

Donna Lorenson
US Head of Communications
817.615.5092 (office)
410.258.8571 (mobile)
[email protected]

IMPORTANT PRODUCT INFORMATION ABOUT THE ORA SYSTEM

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

INTENDED USE: The ORA System uses wavefront aberrometry data in the measurement and analysis of the refractive power of the eye (i.e. sphere, cylinder, and axis measurements) to support cataract surgical procedures.

CONTRAINDICATIONS: The ORA System is contraindicated for patients:
• who have progressive retinal pathology such as diabetic retinopathy, macular degeneration, or any other pathology that the physician deems would interfere with patient fixation;
• who have corneal pathology such as Fuchs’, EBMD, keratoconus, advanced pterygium impairing the cornea, or any other pathology that the physician deems would interfere with the measurement process;
• whose preoperative regimen includes residual viscous substances left on the corneal surface such as lidocaine gel or viscoelastics;
• with visually significant media opacity (such as prominent floaters or asteroid hyalosis) what will either limit or prohibit the measurement process; or
• who have received retro or peribulbar block or any other treatment that impairs their ability to visualize the fixation light.
In addition, utilization of iris hooks during an ORA System image capture is contraindicated, because the use of iris hooks will yield inaccurate measurements.

WARNINGS AND PRECAUTIONS: 
• Significant central corneal irregularities resulting in higher order aberrations might yield inaccurate refractive measurements.
• Post refractive keratectomy eyes might yield inaccurate refractive measurement.
• The safety and effectiveness of using the data from the ORA System have not been established for determining treatments involving higher order aberrations of the eye such as coma and spherical aberrations.
• The ORA System is intended for use by qualified health personnel only.
• Improper use of this device may result in exposure to dangerous voltage or hazardous laser-like radiation exposure.
• Do not operate the ORA System in the presence of flammable anesthetics or volatile solvents such as alcohol or benzene, or in locations that present an explosion hazard.

ATTENTION: Refer to the ORA System Operator’s Manual for a complete description of proper use and maintenance of the ORA System, as well as a complete list of contraindications, warnings and precautions.

IMPORTANT PRODUCT INFORMATION ABOUT VERION REFERENCE UNIT and VERION DIGITAL MARKER

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

INTENDED USES: The VERION Reference Unit is a preoperative measurement device that captures and utilizes a high-resolution reference image of a patient's eye. In addition, the VERION Reference Unit provides pre-operative surgical planning functions to assist the surgeon with planning cataract surgical procedures. The VERION Reference Unit also supports the export of the reference image, preoperative measurement data, and surgical plans for use with the VERION Digital Marker and other compatible devices through the use of a USB memory stick. The VERION Digital Marker links to compatible surgical microscopes to display concurrently the reference and microscope images, allowing the surgeon to account for lateral and rotational eye movements. In addition, details from the VERION Reference Unit surgical plan can be overlaid on a computer screen or the physician's microscope view.

CONTRAINDICATIONS:
The following conditions may affect the accuracy of surgical plans prepared with the VERION Reference Unit: a pseudophakic eye, eye fixation problems, a non-intact cornea, or an irregular cornea. In addition, patients should refrain from wearing contact lenses during the reference measurement as this may interfere with the accuracy of the measurements. The following conditions may affect the proper functioning of the VERION Digital Marker: changes in a patient's eye between pre-operative measurement and surgery, an irregular elliptic limbus (e.g., due to eye fixation during surgery, and bleeding or bloated conjunctiva due to anesthesia). In addition, the use of eye drops that constrict sclera vessels before or during surgery should be avoided.

WARNINGS:
Only properly trained personnel should operate the VERION Reference Unit and VERION Digital Marker. Use only the provided medical power supplies and data communication cable. Power supplies for the VERION Reference Unit and the VERION Digital Marker must be uninterruptible. Do not use these devices in combination with an extension cord. Do not cover any of the component devices while turned on. The VERION Reference Unit uses infrared light. Unless necessary, medical personnel and patients should avoid direct eye exposure to the emitted or reflected beam.

PRECAUTIONS: To ensure the accuracy of VERION Reference Unit measurements, device calibration and the reference measurement should be conducted in dimmed ambient light conditions. Only use the VERION Digital Marker in conjunction with compatible surgical microscopes.

ATTENTION: Refer to the user manuals for the VERION Reference Unit and the VERION Digital Marker for a complete description of proper use and maintenance of these devices, as well as a complete list of contraindications, warnings and precautions.