Eyeworld Supplements

EW San Diego 2015 7 AcrySof ® IQ Intraocular Lenses Caution: Federal (USA) law restricts this device to the sale by or on the order of a physician. Indications: The AcrySof ® IQ posterior chamber intraocular lens is intended for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag. Warning/precaution: Careful preop- erative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Direc- tions for Use labeling. Caution should be used prior to lens encapsulation to avoid lens decentrations or dislocations. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof ® Natural IOL and normal color vision. The effect on vision of the AcrySof ® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glauco- ma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45 degrees C; use only sterile irrigating solutions such as BSS ® or BSS PLUS ® Sterile Intraocular Irrigating Solutions. Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings, and precautions. AcrySof ® IQ ReSTOR ® Intraocular Lenses Caution: Federal (USA) law restricts this device to the sale by or on the order of a physician. Indications: The AcrySof ® IQ ReSTOR ® Posterior Chamber Intraocular Lens (IOL) is intended for primary implantation for the visual correction of aphakia second- ary to removal of a cataractous lens in adult patients with and without presby- opia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag. Warning/precaution: Careful preop- erative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Direc- tions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery. Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. Clinical studies with the AcrySof ® ReSTOR ® lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to sur- gery, physicians should provide prospec- tive patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof ® IQ ReSTOR ® IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof ® Natural IOL and normal color vision. The effect on vision of the AcrySof ® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glauco- ma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45 degrees C; use only sterile irrigating solutions such as BSS ® or BSS PLUS ® Sterile Intraocular Irrigating Solutions. Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings, and precautions. AcrySof ® IQ Toric Intraocular Lenses Caution: Federal (USA) law restricts this device to the sale by or on the order of a physician. Indications: The AcrySof ® IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to remov- al of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision. Warning/precaution: Careful preop- erative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Direc- tions for Use labeling. Toric IOLs should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. All viscoelastics should be removed from both the anteri- or and posterior sides of the lens; residual viscoelastics may allow the lens to rotate. Optical theory suggest that high astigmatic patients (i.e., >2.5 D) may experience spatial distortions. Possible toric IOL related factors may include residual cylindrical error or axis mis- alignments. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof ® IQ Toric Cylinder Power IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof ® Natural IOL and normal color vision. The effect on vision of the AcrySof ® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glauco- ma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45 degrees C; use only sterile irrigating solutions such as BSS ® or BSS PLUS ® Sterile Intraocular Irrigating Solutions. Attention: Reference the Directions for Use labeling 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 (in- cluding 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 myo- pia of up to –12.00 D and up to 6.00 D of astigmatism at the spectacle plane; • the reduction or elimination of hyper- opia up to +6.00 D with and without astigmatic refractive errors up to 5.00 D at the spectacle plane, with a max- imum manifest refraction spherical equivalent of +6.00 D; • the reduction or elimination of natu- rally 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 Topolyz- er ® 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 preoper- ative spherical equivalent shift over one year prior to surgery, exclusive of chang- es due to unmasking latent hyperopia. Contraindications: The WaveLight ® Ex- cimer 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; • severe allergies; • a history of glaucoma; • an unreliable preoperative wavefront examination that precludes wavefront- guided treatment; or • a poor quality preoperative topogra- phy map that precludes topography- guided LASIK treatment. The wavefront-guided LASIK procedure requires accurate and reliable data from the wavefront examination. Every step of every wavefront measurement that may be used as the basis for a wavefront-guid- ed LASIK procedure must be validated by the user. Inaccurate or unreliable data from the wavefront examination will lead to an inaccurate treatment. Topography-guided LASIK requires pre- operative topography maps of sufficient quality to use for planning a topography -guided LASIK treatment. Poor quality topography maps may affect the accu- racy of the topography-guided LASIK treatment and may result in poor vision after topography-guided LASIK. Precautions: The safety and effectiveness of the WaveLight ® Excimer Laser Systems have not been established for patients with: • progressive myopia, hyperopia, astig- matism and/or mixed astigmatism, ocular disease, previous corneal or intraocular surgery, or trauma in the ablation zone; • corneal abnormalities including, but not limited to, scars, irregular astigma- tism and corneal warpage; • residual corneal thickness after abla- tion of less than 250 microns due to the increased risk for corneal ectasia; • pupil size below 7.0 mm after mydriat- ics where applied for wavefront-guided ablation planning; • history of glaucoma or ocular hypertension of >23 mmHg; • taking the medication sumatriptan succinate (Imitrex*); • corneal, lens and/or vitreous opacities including, but not limited to cataract; • iris problems including, but not limited to, coloboma and previous iris surgery compromising proper eye tracking; or • taking medications likely to affect wound healing including (but not limited to) antimetabolites. In addition, safety and effectiveness of the WaveLight ® Excimer Laser Systems have not been established for: • treatments with an optical zone <6.0 mm or >6.5 mm in diameter, or an ablation zone >9.0 mm in diameter; or • wavefront-guided treatment targets different from emmetropia (plano) in which the wavefront calculated defo- cus (spherical term) has been adjusted. In the WaveLight ® Excimer Laser System clinical studies, there were few subjects with cylinder amounts >4 D and ≤6 D. Not all complications, adverse events, and levels of effectiveness may have been determined for this population. Important product information

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