The VERION™ Image Guided System is an entirely new way of looking at cataract refractive surgery. Instead of checking for refractive error at the end of the procedure, the VERION™ Image Guided System helps minimize potential sources of error during each step of the surgical process. From patient imaging to surgical planning to procedural guidance, the VERION™ Image Guided System is designed to help consistently hit the cataract refractive target.
Currently the VERION™ Image Guided System is used in six practices in the United States to include (Cape Fear Eye Associates, PA) and several outside of the United States. The goal is to use a single reference image of a patient among all of the devices while guiding and planning the patient’s treatment, as well as performing the treatment and tracking outcomes. It is a way to help standardize outcomes and reduce variability.
- Improve clinical efficiency
- Ensure surgical consistency
- Optimize visual outcomes
Precise Reference Image for Registration and Tracking While taking key diagnostic measurements, the VERION™ Reference Unit simultaneously takes a high-resolution, digital reference image of the patient’s unique eye, capturing scleral vessels, limbus and iris landmarks. This “fingerprint of the eye” is used to:
- Register and track the eye throughout the procedure
- Automatically imports all measurement data into the surgical planner and prepopulates data fields
- Provide a visual reference of all incisions, capsulotomy and IOL positioning
Comprehensive Astigmatism Management
The VERION™ Reference Unit also provides advanced astigmatism management to help minimize residual cylinder. This includes calculating:
- Optimum incision locations
- Toric lens power
- Corneal relaxing incisions
- Surgically induced astigmatism (SIA)
Allowing for complete customization, the VERION™ Image Guided System accommodates a full spectrum of surgical preferences and equipment.
VERION™ Digital Marker
The VERION™ Digital Marker displays patient information and images from the Reference Unit to facilitate incision and IOL alignment. The system features a tracking overlay that aligns all incisions and IOLs in real-time, automatically compensates for cyclorotation, eliminates the need for manual eye markings, registers the patient for accurate centering and alignment of multifocal and toric IOLs and allows documentation of data to optimize procedures over time.
VERION™ REFERENCE UNIT AND VERION™ DIGITAL MARKER IMPORTANT SAFETY INFORMATION
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 preoperative surgical planning functions that utilize the reference image and preoperative 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 preoperative 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.