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Issue link: https://daily.eyeworld.org/i/124056
8 EW San Francisco 2013 Monday, April 22, 2013 Important safety information LENSTAR LS 900* Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Indications: The LENSTAR LS 90* 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 (intraocular lens) for implantation after removal of the natural crystalline lens following cataract removal. The LENSTAR LS 900 measures: • Axial eye length • Corneal thickness • Anterior chamber depth • Aqueous depth • Lens thickness • Radii of curvature of flat and steep meridian • Axis of the flat meridian • White to white distance • Pupil diameter Warnings: Measurements can be carried out with dilated or undilated pupils. The A-scan (axial eye length, corneal thickness, anterior chamber depth and lens thickness), keratometry and white-to-white distance measurement are not influenced by dilatation status. Dilatation status, however, does have a bearing on pupillometry. The light from this instrument may be dangerous. The risk of eye damage increases with the irradiation period. Precautions: Users should check measurement readings for plausibility. This includes the verification of the A-scan and the cursors. The operator should also take into account the type (e.g., posterior subcapsular cataract) and density of the cataract when evaluating plausibility. For best results, patients should keep the eye as wide open as possible during measurements. Blinking is permitted, but should be kept to a minimum. Attention: Reference the Instructions for Use for a complete listing of indications, warnings, and precautions. *LENSTAR is a registered trademark of Haag-Streit. 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 preoperative 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 (USA) law restricts this device to the sale by or on the order of a physician. 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 preoperative 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 indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically 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 (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 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 preoperative 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 viscoelastics should be removed from both the anterior and posterior sides of the lens; residual 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. 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 MIX13251SOV