Eyeworld Daily News

2017 ASCRS Los Angeles Daily Monday

EyeWorld Today is the official daily of the ASCRS Symposium & Congress. Each issue provides comprehensive coverage editorial coverage of meeting presentations, events, and breaking news

Issue link: https://daily.eyeworld.org/i/820965

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Page 95 of 96

7 of the company, the innova- tion over the years to keep the laser current, and the service. I approached it as if I was considering a stock to purchase. This is a tremen- dous consideration when choosing where to make a significant investment. Buying a femtosecond laser may not be for everyone and this may become ev- ident as you build your business plan. However, the LenSx Laser is mobilized through Sightpath Medi- cal * . Some of my peers who believe in this technology, but don't have the volume to support a purchase, have used Sightpath Medical* with great success. They believe Sightpath Medical* is reliable and consistent, allowing them to operate while feeling quite comfort- able and confident. This company has a dedicated engineer who stays with you the whole day and sim- ply rolls it back out upon completion until your next scheduled contract date. Furthermore, I was im- pressed that the LenSx Laser had five upgrades in my first 2 years of owning it. The technology was con- tinuing to evolve, and the company was not charging me more as the enhance- ments were being applied. There have been two more recent revisions and more are on the way this year and next. Alcon has lis- tened to their customers by incorporating many of their suggestions on how to im- prove efficacy, predictabili- ty, and procedural flow. When the laser in my office went down, a technician came within an hour, and the part was flown from California. The technician stayed in the hotel and was there at 6 in the morning to fix it so I could finish my cases the next morning. That kind of service and the commitment to technology from the company solidified my choice. It's important to make sure, in this fast- paced environment, that the technology doesn't become obsolete or frustrating. n Scott LaBorwit, MD, is assistant professor, part- time faculty, at the Wilmer Eye Institute, Johns Hopkins Hospital. He can be reached at sel104@me.com. * Trademarks are property of their respective owners. This supplement was pro- duced by EyeWorld and spon- sored by Alcon. Dr. LaBorwit is a consultant for Alcon and received compensation from Alcon for his contributions to this supplement. LenSx Laser Important Product Information for Cataract Treatment Caution Federal Law restricts this device to sale and use by or on the order of a physician or licensed eye care practitioner. Indications: The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacof- ragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. Restrictions • Patients must be able to lie flat and motion- less in a supine position. • Patient must be able to understand and give an informed consent. • Patients must be able to tolerate local or topical anesthesia. • Patients with elevated IOP should use topical steroids only under close medical supervision. Contraindications • Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength • Descemetocele with impending corneal rupture • Presence of blood or other material in the anterior chamber • Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy • Conditions which would cause inadequate clearance between the intended capsuloto- my depth and the endothelium (applicable to capsulotomy only) • Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape • Corneal thickness requirements that are beyond the range of the system • Corneal opacity that would interfere with the laser beam • Hypotony or the presence of a corneal implant • Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) • History of lens or zonular instability • Any contraindication to cataract or kerato- plasty • This device is not intended for use in pediat- ric surgery. Warnings The LenSx Laser System should only be oper- ated by a physician trained in its use. The LenSx Laser delivery system employs one sterile disposable Patient Interface consisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. The disposables used in conjunction with ALCON instrument products constitute a complete surgical system. Use of disposables other than those manufactured by Alcon may affect system performance and create poten- tial hazards. The physician should base patient selection criteria on professional experience, published literature, and educational courses. Adult patients should be scheduled to undergo cataract extraction. Precautions • Do not use cell phones or pagers of any kind in the same room as the LenSx Laser. • Discard used Patient Interfaces as medical waste. Complications • Capsulotomy, phacofragmentation, or cut or incision decentration • Incomplete or interrupted capsulotomy, fragmentation, or corneal incision proce- dure • 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 Attention Refer to the LenSx Laser Operator's Manual for a complete listing of indications, warnings and precautions. ORA SYSTEM Important Product information Caution: Federal (USA) law restricts this device to the sale by or on the order of a physician. Indications: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Intended use: The ORA SYSTEM uses wavefront aberrome- try 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. Contraindictions: There are no known contraindications for this device. Warnings and precautions: The following conditions may make it difficult to obtain accurate readings using the ORA SYSTEM • Patients having progressive retinal pathol- ogy 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 pte- rygium 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 mea- surements. 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 in- volving 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 hazard- ous 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, as well as a complete list of con- traindications, warnings and precautions.

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