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verion system

VERION™ Image Guided System

Richard Mackool, MD, and Stephen Slade, MD, discuss their initial experiences with the VERION Image Guided System. They talk about incorporating the system into the clinic workflow and how the image overlay helps to improve accuracy.



Designed to Achieve a High Level of Accuracy
in Cataract Surgery

by Jack T. Holladay, MD


Important Product Information for the 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 order to determine the radii and corneal curvature of steep and flat axes, limbal position and diameter, pupil position and diameter, and corneal reflex position. In addition, the VERION Reference Unit provides pre-operative surgical planning functions that utilize the reference image and pre-operative measurements to assist with planning cataract surgical procedures, including the number and location of incisions and the appropriate intraocular lens using existing formulas. The VERION Reference Unit also supports the export of the high-resolution 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, the planned capsulorhexis position and radius, IOL positioning, and implantation axis 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.
Only trained personnel familiar with the process of IOL power calculation and astigmatism correction planning should use the VERION Reference Unit. Poor quality or inadequate biometer measurements will affect the accuracy of surgical plans prepared with the VERION Reference Unit.
The following contraindications 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.
Only use the provided medical power supplies and data communication cable. The 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.
Only use a VERION USB stick to transfer data. The VERION USB stick should only be connected to the VERION Reference Unit, the VERION Digital Marker, and other compatible devices. Do not disconnect the VERION USB stick from the VERION Reference Unit during shutdown of the system.
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.