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EW San Diego 2015 8 Complications Cataract surgery AEs/complications • Capsulotomy, phacofragmenta- tion, or cut or incision decentration • Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure • Capsular tear • Corneal abrasion or defect • Pain • Infection • Bleeding • Damage to intraocular structures • Anterior chamber fluid leakage, anterior chamber collapse • Elevated pressure to the eye Corneal flap AEs/complications • Corneal edema • Corneal pain • Epithelial in-growth • Epithelial defect • Infection • Flap decentration • Incomplete flap creation • Flap tearing or incomplete lift-off • Free cap Attention Refer to the LenSx ® Laser Operator's Manual for a complete listing of in- dications, warnings and precautions. 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 measure- ments) to support cataract surgical procedures. Contraindications: The ORA ™ Sys- tem is contraindicated for patients: • who have progressive retinal pathology such as diabetic reti- nopathy, 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 in- cludes residual viscous substances left on the corneal surface such as lidocaine gel or viscoelastics; • with visually significant me- dia opacity (such as prominent floaters or asteroid hyalosis) that will either limit or prohibit the measurement process; or • who have received retro or peribulbar block or any other treatment that impairs their abili- ty to visualize the fixation light. In addition, utilization of iris hooks during an ORA ™ System image cap- ture is contraindicated because the use of iris hooks will yield inaccurate measurements. Warnings and precautions: • Significant central corneal irreg- ularities 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 ™ Sys- tem 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 anes- thetics or volatile solvents such as alcohol or benzene, or in locations that present an explosion hazard. Attention: Refer to the ORA ™ Sys- tem Operator's Manual for a com- plete description of proper use and maintenance of the ORA ™ System, as well as a complete list of contraindi- cations, warnings, and precautions. Verion ® Image Guided System 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 ® Refer- ence Unit is a preoperative mea- surement device that captures and utilizes a high-resolution reference image of a patient's eye. In addition, the Verion ® Reference Unit provides preoperative surgical planning func- tions to assist the surgeon with plan- ning 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 con- currently the reference and micro- scope 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 pseu- dophakic 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 preoperative measurement and surgery, an irregular elliptic lim- bus (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 ® Ref- erence Unit and the Verion ® Digital Marker must be uninterruptible. Do not use these devices in combina- tion with an extension cord. Do not cover any of the component devices while turned on. The Verion ® Refer- ence 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 measure- ments, 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 manu- als 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 contraindi- cations, warnings, and precautions. MIX15138JS-A

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