Eyeworld Supplements

12 AcrySof IQ intraocular lenses Caution: Federal (U.S.) law restricts this device to 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 pre-operative 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 Directions 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., glaucoma, 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 (U.S.) law restricts this device to 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 secondary to removal of a cataractous lens in adult patients with and without presbyopia, 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 pre-op 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 Directions 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 indi- cated that posterior capsule opacification (PCO), when present, developed earlier into clini- cally significant PCO. 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 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., glaucoma, 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 (U.S.) law restricts this device to sale by or on the order of a physician. Indications: The AcrySof IQ Toric posterior chamber intraocular lens is intended for pri- mary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal 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 pre-operative 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 Directions 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 vis- coelastics should be removed from both the anterior and posterior sides of the lens; resid- ual viscoelastics may allow the lens to rotate. Optical theory suggests 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 misalignments. 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., glaucoma, 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. LENSTAR LS 900 Optical Biometer The LENSTAR LS 900 Optical Biometer is a non-invasive, non-contact OLCR (optical low-coherence reflectometry) biometer used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL for implantation after removal of the natural crystalline lens following cataract removal. The LENSTAR LS 900 Optical Biometer measures: • Axial eye length • Corneal thickness • Anterior chamber depth • Lens thickness • Radii of curvature of flat and steep meridian • Axis of the flat meridian • White to white distance • Pupil diameter LenSx Laser Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. Indication: 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, phacofragmentation, 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 motionless 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 that would cause inadequate clearance between the intended capsulotomy 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, glaucoma, 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) • This device is not intended for use in pediatric surgery • A history of lens with zonular instability • Any contraindication to cataract or keratoplasty surgery Attention: Reference the Directions for Use labeling for a complete listing of indications, warnings, and precautions. Warnings: The LenSx Laser system should only be operated by a physician trained in its use. The LenSx Laser delivery system employs one sterile disposable LenSx Laser 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 potential 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. 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 EW Chicago 2012 Sunday, April 22, 2012 12 MIX12044SOV Important safety information Alcon Sunday supplement_Chicago2012-12pages_Layout 1 4/20/12 4:51 PM Page 12

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