Eyeworld Daily News

EW Boston 2014 7 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. AEs/Complications: • Capsulotomy, phacofragmentation, 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 Attention: Refer to the LenSx Laser Operator's Manual for a complete listing of indications, warnings and precautions. ProVisc Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Indication: ProVisc OVD is indicated for use as an ophthalmic surgical aid in the anterior segment during cataract extraction and intraocular lens (IOL) implantation. Ophthalmic viscoelastics serve to maintain a deep anterior chamber during anterior segment surgery allowing reduced trauma to the corneal endothelium and surrounding ocular tissues. They help push back the vitreous face and prevent formation of a flat chamber during surgery. Contraindications: At present there are no known contraindications of the use of ProVisc Ophthalmic Viscosurgical Device when used as recommended. Warnings/Precautions: • Postoperative increases in intraocular pressure have been reported with sodium hyaluronate products. The IOP should be carefully monitored and appropriate therapy instituted if significant increases should occur. It is recommended that ProVisc OVD be removed by irrigation and/or aspiration at the close of surgery. Do not overfill anterior chamber. Although sodium hyaluronate is a highly purified biological polymer the physician should be aware of the potential allergic risks inherent in the use of any biological material; care should be used in patients with hypersensitivity to any components in this material. Cannula assembly instructions should be followed to prevent patient injury. • Postoperative inflammatory reactions such as hypopyon and iritis have been reported with the use of ophthalmic viscoelastics, as well as incidents of corneal edema, corneal decompensation, and a transient rise intraocular pressure. Attention: Reference the directions for use for a complete listing of indications, warnings and precautions. 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 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. VISCOAT Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Indication: VISCOAT OVD is indicated for use as a surgical aid in anterior segment procedures including cataract extraction and intraocular lens (IOL) implantation. VISCOAT OVD maintains a deep chamber during anterior segment surgeries, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. Contraindications: At present there are no known contraindications of the use of VISCOAT Ophthalmic Viscosurgical Device when used as recommended. Warnings/Precautions: • Failure to follow "Directions for Use" on attachment of the cannula or use of an alternate cannula may result in cannula detachment. • Precautions are limited to those normally associated with the surgical procedure being performed. Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risks inherent in the use of any biological material. • A transient rise in intraocular pressure in the early postoperative period may be expected due to the presence of sodium hyaluronate, which has been shown to effect such a rise. It is therefore recommended that VISCOAT OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of the surgery to minimize postoperative IOP increases. Do not overfill anterior chamber. Attention: Reference directions for use for a complete listing of indications, warnings and precautions. WaveLight Excimer Laser Systems This information pertains to all WaveLight Excimer Laser Systems, including the WaveLight ALLEGRETTO WAVE, the ALLEGRETTO WAVE Eye-Q , and the WaveLight EX500. Caution: Federal (U.S.) law restricts the WaveLight Excimer Laser Systems to sale by or on the order of a physician. Only practitioners who are experienced in the medical mangement and surgical treatment of the cornea, who have been trained in laser refractive surgery (including laser calibration and operation) should use a WaveLight Excimer Laser System. Indications: FDA has approved the WaveLight Excimer Laser systems for use in laser-assisted in situ keratomileusis (LASIK) treatments for: • the reduction or elimination of myopia of up to –12.00 D and up to 6.00 D of astigmatism at the spectacle plane; • the reduction or elimination of hyperopia up to +6.00 D with and without astigmatic refractive errors up to 5.00 D at the spectacle plane, with a maximum manifest refraction spherical equivalent of +6.00 D; • the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane; and • the wavefront-guided reduction or elimination of myopia of up to –7.00 D and up to 3.00 D of astigmatism at the spectacle plane. In addition, FDA has approved the WaveLight ALLEGRETTO WAVE Eye-Q Excimer Laser System, when used with the WaveLight ALLEGRO Topolyzer and topography-guided treatment planning software for topography-guided LASIK treatments for the reduction or elimination of up to –9.00 D of myopia, or for the reduction or elimination of myopia with astigmatism, with up to –8.00 D of myopia and up to 3.00 D of astigmatism. The WaveLight Excimer Laser Systems are only indicated for use in patients who are 18 years of age or older (21 years of age or older for mixed astigmatism) with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia. Contraindications: The WaveLight Excimer Laser Systems are contraindicated for use with patients who: • are pregnant or nursing; • have a diagnosed collagen vascular, autoimmune or immunodeficiency disease; • have been diagnosed with keratoconus or if there are any clinical pictures suggestive of keratoconus; • are taking isotretinoin (Accutane*) and/or amiodarone hydrochloride (Cordarone*); • have severe dry eye; • have corneas too thin for LASIK; • have recurrent corneal erosion; • have advanced glaucoma; or • have uncontrolled diabetes. Warnings: The WaveLight Excimer Laser Systems are not recommended for use with patients who have: • systemic diseases likely to affect wound healing, such as connective tissue disease, insulin dependent diabetes, severe atopic disease or an immunocompromised status; • a history of Herpes simplex or Herpes zoster keratitis; • significant dry eye that is unresponsive to treatment;

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