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MODEL SN6AT3, SN6AT4, SN6AT5 - 23 Pages

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MODEL SN6AT3, SN6AT4, SN6AT5

Catalog excerpts

PRODUCT INFORMATION Alcon Laboratories, Inc.

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ENGLISH PRODUCT INFORMATION Alcon Laboratories, Inc. STERILE UV and Blue Light Filtering Acrylic Foldable Toric Aspheric Optic Single-Piece Posterior Chamber Lenses CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. DESCRIPTION The AcrySof® IQ Toric Posterior Chamber Intraocular Lens (IOL) is a UV-absorbing foldable intraocular lens (IOL). The single-piece design (see Figure 1 and Table 1) consists of a high refractive index material with proprietary blue light filtering chromophore which filters light in a manner that approximates the human...

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Table 1 Physical Characteristics of AcrySof® IQ Toric IOLs Model Characteristics Collectively referred to as Model SN6ATT Optic Type Biconvex Toric Aspheric Optic Optic / Haptic Material Ultraviolet and blue light filtering Acrylate/Methacrylate Copolymer UV cutoff at 10% T: 402 nm* IOL Powers (spherical equivalent diopters) IOL Cylinder Power (diopters) For available power range see Alcon Product Guide 1.50 diopter Haptic Configuration Haptic Angle 0º Figure 2 Spectral Transmittance Curves (Percentage of Ultraviolet Transmittance) 4 yr - 53 yr old range, crystalline lens Human lens data...

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Modulation Transfer Function (MTF) -3mm Aperture 1 - SN6AT5: AcrySof® IQ Toric IOL (Aspheric) - SN60T5: AcrySoflS> Toric IOL (Spheric) - SN60AT: Aery Sot® IOL (Spheric)_ Spatial Frequency (Ip/mm) Modulation Transfer Function (MTF) -5mm Aperture 1 — SN6AT5: AcrySof® IQ Toric IOL (Asptiwlc) . --SN60T5: AcrySof® Toric IOL (Spheric) — SMBOAT: AcrySoFB IOL (Spheric)_ Spatial Frequency (Ip/mm) 1 Image quality was characterized by measuring MTF ir adult human spherical aberration Using the modified ITM AcrySof® IQ Tone lOLs are intended to be positioned in the posterior chamber of the eye,...

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IOL Cylinder Power (diopters) Cylinder Power at Corneal Plane (diopters*) * Based on an average pseudophakic human eye 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. WARNINGS 1. This lens should...

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9. Use only sterile intraocular irrigating solutions such as BSS® or BSS PLUS® solution to rinse and/or soak lenses. 10. Accurate keratometry and biometry in addition to the use of the Toric Calculator (www.acrysoftoriccalculator.com) are recommended to achieve optimal visual outcomes. CALCULATION OF LENS POWER Accurate keratometry and biometry is essential to successful visual outcomes. Preoperative calculation of the required spherical equivalent lens power for these posterior chamber intraocular lenses should be determined by the surgeon’s experience, preference, and intended lens...

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Registration Card that is enclosed in the lens box and mailing it to Alcon Laboratories, Inc. Patient registration is essential for Alcon Laboratories, Inc. long-term patient follow-up program and will assist us in responding to adverse event reports. The Patient Identification Card included in the package is to be completed and given to the patient, together with instructions to keep the card as a permanent record to be shown to any eye care practitioner the patient consults in the future. Adverse events that may reasonably be regarded as lens-related and that were not previously expected...

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Table 5B Uncorrected Distance Visual Acuity by Age Category, Status at Form 5 - Lens Model SA60AT, All Implanted Acuity Age Category At the Form 5 visit, shown in Figure 5A, 93.8% of Model SA60TT subjects achieved 20/40 or better UCDVA (first operative eye of the All Implanted data set) compared to 77.1% of the subjects implanted with the control Model SA60AT. The difference in UCDVA between Models SA60TT and SA60AT was statistically significant (all p-values < 0.0001) in favor of Model SA60TT. Figure 5A Cumulative UCDVA, Status at Form 5, Model SA60TT vs. Control Figures 5B – 5D show a...

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batter battar batter batter 20/40 Cumulative UCDVA Figure 5C shows that the difference in cumulative UCDVA between Models SA60T4 and SA60AT was statistically significant (all p-values < 0.0082) for each visual acuity category (20/25 or better, 20/32 or better and 20/40 or better) in favor of Model SA60T4 with the exception of the 20/20 or better category. batter batter batter batter 20/40 Cumulatlva UCDVA Figure 5D shows that the difference in cumulative UCDVA between Models SA60T5 and SA60AT was statistically significant (all p-values < 0.0171) for each visual acuity category (20/20 or...

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Figure 5D Cumulative UCDVA, Model SA60T5 vs. Control, Form 5, All Implanted AcrySof® TORIC INTRAOCULAR LENS BEST SPECTACLE DISTANCE CORRECTED VISUAL ACUITY A summary of best spectacle corrected distance visual acuity (BSCDVA) achieved at six months postoperatively among subjects who did not have any visually significant preoperative pathology or macular degeneration at any time (Best Case) is presented in Table 6A. Visual acuity achieved by the overall subject population is shown in Table 6C. Control data are found for the same data sets in Tables 6B and 6D, respectively. Of the first...

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Table 6C BSCDVA by Age Category, Status at Form 5 - Lens Model SA60TT, All Implanted Acuity Age Category Table 6D BSCDVA by Age Category, Status at Form 5 - Lens Model SA60AT, All Implanted Acuity Age Category Sample size Figures 6A – 6C show a summary of cumulative best corrected visual acuities for each Toric model compared to the control subjects in the same cylinder range for the All Implanted dataset. Figure 6A Cumulative BSCDVA, Model SA60T3 vs. Control, Form 5, All Implanted

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Figure 6B Cumulative BSCDVA, Model SA60T4 vs. Control, Form 5, All Implanted Figure 6C Cumulative BSCDVA, Model SA60T5 vs. Control, Form 5, All Implanted AcrySof® TORIC INTRAOCULAR LENS ABSOLUTE RESIDUAL REFRACTIVE CYLINDER Figures 7A through 7C demonstrate that residual refractive cylinder values were statistically significantly lower among those subjects implanted with either an AcrySof® Toric IOL Model SA60T3, SA60T4 or SA60T5 when compared to the corresponding subjects implanted with the control Model SA60AT. Subjects implanted with an AcrySof® Toric IOL Model SA60T3 showed a 62.4% mean...

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