ORA

THE CHOICE FOR A CUSTOMIZED PROCEDURE IS ALL YOURS

Cataracts are a natural part of the aging process. You didn’t choose them, but you did choose your doctor — and you can choose how they’re treated. By now, you may have heard about customized cataract procedures designed to correct conditions such as astigmatism and presbyopia during your cataract procedure. The ORA SYSTEM® with VerifEye®+ technology is one of the technologies your doctor will use to tailor your cataract procedure to your unique eye.

Basic cataract surgery is generally a safe and common procedure1 that removes your cloudy lens but does not addressany other visual disorders. To ensure best-case results after basic cataract surgery, you may need follow-up visits and glasses to correct visual disorders like astigmatism — potentially delaying improvements to your vision Like a GPS, the ORA SYSTEM® helps your doctor navigate your unique eye during surgery. This provides your doctor with the real-time guidance they need for more satisfactory results before you leave the operating room.

FAQS

1. How does the ORA SYSTEM® with VerifEye®+ technology work? The ORA SYSTEM® assesses your eye during cataract surgery, much like a GPS system tracks your progress on the road. With this data, your doctor can make real-time adjustments to arrive at a better result.

2. How will customized cataract surgery enhance my outcomes? During a customized procedure, your doctor can use the ORA SYSTEM® to analyze the state of your eye during the procedure to confirm your vision correction needs. This differs from basic cataract surgery, where visual disorders are addressed afterward, during follow-up visits.

3. Does customized cataract surgery cost more? While customized procedures are associated with an increased expense compared with basic cataract surgery, the investment may help reduce the need for glasses.

ORA SYSTEM® 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: There are no known contraindications for this device.

WARNINGS AND PRECAUTIONS:
The following conditions may make it difficult for your doctor to obtain accurate readings using the ORA SYSTEM®: · Patients having progressive retinal pathology such as diabetic retinopathy, macular degeneration, or any other pathology that the physician deems would interfere with patient fixation;
· Patients having 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;
· Patients for which the preoperative regimen includes residual viscous substances left on the corneal surface such as lidocaine gel or viscoelastics;
· Visually significant media opacity, such as prominent floaters or asteroid hyalosis, will either limit or prohibit the measurement process; or
· Patients having received retro or peribulbar block or any other treatment that impairs their ability to visualize the fixation light.
· Use of iris hooks during an ORA SYSTEM® image capture will yield inaccurate measurements.

IN ADDITION:
· 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. The ORA SYSTEM® should not be operated in the presence of flammable anesthetics or volatile solvents such as alcohol or benzene, or in locations that present an explosion hazard.

ATTENTION:
Ask your doctor for more information about the ORA SYSTEM® and its use in your cataract procedure

YOUR EYES ARE UNIQUE.

Let your doctor know you’re ready to join the half a million cases who have chosen a more customized cataract procedure.

1. Mayo Clinic. Cataract Surgery: Overview. http://www.mayoclinic.org/tests-procedures/ cataract-surgery/home/ovc-20229526. Accessed October 19, 2016.
2. Cionni R. Randomized prospective comparison of toric IOL power and axis determination by intraoperative aberrometry versus toric calculator. Presented at: ASCRS; April 17-21, 2015; San Diego, CA.
3. Ianchulev T, Hoffer K, Yoo S, et al. Intraoperative refractive biometry for predicting intraocular lens power calculation after prior myopic refractive surgery. Ophthalmology. 2014;121(1):57-60.