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ACTIVE FOCUS™ Optical Design
important product Information
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IMPORTANT PRODUCT INFORMATION
©2020 Alcon Inc. 5/20 US-ACR-1900025
of energy to the eye *
0.75% off target ≥5°, by estimated market usage** n=3,556
more likely to rotate than AcrySof® IQ Toric
AcrySof®IQ Toric IOL Profile
Distance and Stability.
6 mm optic provides:
The only multifocal optic featuring a central portion 100% dedicated to distance
*3 mm pupil energy distribution: distance + near.
1.86% off target ≥5°,by estimated market usage** n=1,953
AcrySof® IQ ReSTOR® Family of Multifocal IOLs Important Product Information
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 Multifocal IOLs include AcrySof® IQ ReSTOR® and AcrySof® ReSTOR® Toric and are 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. In addition, the AcrySof® IQ ReSTOR® Toric IOL is intended to correct pre-existing astigmatism. The lenses are intended to be placed in the capsular bag. WARNINGS/PRECAUTIONS: 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 for each IOL. 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. The ReSTOR® Toric IOL 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. Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. A reduction in contrast sensitivity may occur in low light conditions. Visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary; some patients may need glasses when reading small print or looking at small objects. Posterior capsule opacification (PCO), when present, may develop earlier into clinically significant PCO with multifocal IOLs. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon informing them of possible risks and benefits associated with the AcrySof® IQ ReSTOR® IOLs. Do not resterilize; do not store over 45° C; use only sterile irrigating solutions such as BSS® or BSS PLUS® Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for each IOL for a complete listing of indications, warnings and precautions.
IMPORTANT SAFETY INFORMATION
1. Alcon Data on File.
2. Vega F, Alba-Bueno F, Millán MS, et al. Halo and through-focus performance of four diffractive multifocal and intraocular lenses. Invest Ophthalmol Vis Sci. 2015;56:3967-3975.
3. Potvin R, et al. Toric intraocular lens orientation and residual refractive astigmatism: an analysis. Clin Ophthalmol. 2016;10:1829-1836.
4. Alcon Data on File (Oct 17, 2016).
5. Ong M, Wang L, Karakelle M. Fibronectin adhesive properties of various intraocular lens materials. Invest Ophthalmol Vis Sci. 2013;54(15):819-B0043.
6. Linnola RJ, Sund M, Ylonen R, et al. Adhesion of soluble fibronectin, laminin, collagen type IV to intraocular lens materials. J Cataract Refract Surg. 1999;25(11):1486- 1491.
7. Boureau C, et al. Incidence of Nd:YAG laser capsulotomies after cataract surgery: comparison of 3 square edge lenses of different composition. Can J Ophthalmol. 2009;44:165-170.
8. Apple DJ, Peng Q, Visessook N, et al. Eradication of posterior capsule opacification: documentation of a marked decrease in Nd:YAG laser posterior capsulotomy rates noted in an analysis of 5,416 pseudophakic human eyes obtained postmortem. Ophthalmology. 2001;108(3):505-518.
9. Fisher B, Potvin R. Clinical outcomes with distance-dominant multifocal and monofocal intraocular lenses in post-LASIK cataract surgery planned using an intraoperative aberrometer. Clin Exp Ophthalmol. 2018;doi:10.1111/ceo.13153.
10. Henderson B, Solomon K, Masket S, et al. A survey of potential and previous cataract-surgery patients: what the ophthalmologist should know. Clin Ophthalmol. 2014;8:1595-1602
11. AcrySof® IQ Toric IOL Directions for Use.
12. TECNIS** Toric Aspheric IOL Specification Sheet. Abbott Medical**, 2015
13. Wirtitsch MG, et al. Effect of haptic design on change in axial lens position after cataract surgery. J Cataract Refract Surg. 2004;30(1):45-51.
14. Eldaly MA, Mansour KA. Personal A-constant in relation to axial length with various intraocular lenses. Indian J Ophthalmol. 2014;62(7):788-791.
15. Nejima R, et al. Prospective intrapatient comparison of 6.0-millimeter optic single-piece and 3-piece hydrophobic acrylic foldable intraocular lenses. Ophthalmology. 2006;113(4):585- 590.
16. Lane SS, Ernest P, Miller KM, Hileman KS, Harris B, Waycaster CR. Comparison of clinical and patient reported outcomes with bilateral AcrySof® Toric or spherical control intraocular lenses. J Refract Surg. 2009;25(10):899-901.
17. Lane SS, Burgi P, Milios GS, Orchowski MW, Vaughan M, Schwarte E. Comparison of the biomechanical behavior of foldable intraocular lenses. J Cataract Refract Surg. 2004;30:2397-2402.
Unique Optic Design, Unique Benefit
“In evidence from thousands of cases entered into AstigmatismFix.com,* TECNIS† Toric IOLs were more likely to rotate ≥ 5° post-op than AcrySof® IQ Toric IOLs.”
*AstigmatismFix.com Is An Online Calculator To Help Surgeons Determine If A Previously Placed Toric IOL Is Ideally Aligned. The Analysis Dataset Includes 5,674 Entries, With Each Unique Lens And Intended Orientation Identified, In Addition To Post-Operative IOL Orientation ≥5° From Intended Axis. The Dataset Was Weighted Based On The Estimated Market Usage Of Each Lens. The Full Evaluation Included AcrySof® IQ Toric, TECNIS† Toric, Trulign† Toric and Staar† Toric IOLs.10
Engineered for optimal refractive predictability
Tecnis† Toric IOL Profile
• Excellent axial positioning and rotational stability for refractive predictability
• No observed rotational bias
Offset haptics may be more prone to hyperopic shift.
Tecnis† Toric IOL
• Observed bias toward counterclockwise rotation
• Offset haptic design may increase risk of hyperopic shift
†Trademarks are property of their respective owners
Distance Visual Acuity Comparable to a Monofocal IOL — in Post-LASIK eyes
Even In Some Of Your Most Challenging Patients, ReSTOR®+2.5 D IOLs With ACTIVEFOCUS™ Optical Design Can Help You Achieve Visual Acuity Comparable To AcrySof®IQ Monofocal IOLs.§
• IOLs With ACTIVEFOCUS™ Optical Design (n=23) vs. AcrySof®IQ Monofocal IOLs (n=18)
• Comparable Percentage Of Eyes With 20/25 UCDVA or Better (p=0.41)
**Scaled to mm from microns for readability
¶In a retrospective chart review of post-LASIK cataract surgical outcomes from one surgeon at one surgical center involving intraoperative aberrometry and bilateral implantation of either AcrySof® IQ ReSTOR® +2.5 D or AcrySof® IQ monofocal IOLs. No statistically significant difference in distance visual acuity as determined by Chisquared test (p=0.41).
†Trademarks are the property of their respective owners.
Distance Visual Acuity Comparable to a Monofocal IOL — in Post-LASIK eyes