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ORA™ SYSTEM WITH VERIFEYE+™ TECHNOLOGY IMPORTANT PRODUCT INFORMATION
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.