Articles: PDF OnlyLong-term clinical results of AMO PhacoFlex model SI-18 intraocular lens implantationSteinert, R. F. M.D.a,*; Bayliss, B. B.S.b; Brint, S. F. M.D.c; Giamporcaro, J. E. B.S.b; Hunkeler, J. D. M.D.dAuthor Information aFrom the Center for Eye Research and the Harvard Medical School, Boston, Massachusetts bAllergan Medical Optics, Irvine, California cTulane University School Of Medicine, and Eye Surgery Center of Louisiana, New Orleans, Louisiana dHunkeler Eye Surgery Center, Kansas City, Missouri *Reprint requests to R.F. Steinert, M.D., 50 Staniford Street, Boston, Massachusetts 02114. Presented in part at the Symposium on Cataract, IOL and Refractive Surgery, San Diego, April 1993; the Welsh Congress, Houston, September 1992; European Society of Cataract and Refractive Surgery, Paris, September 1992; and European Society of Cataract and Refractive Surgeons, Innsbruck, August–September 1993. This study was supported in part by Allergan Medical Optics, Irvine, California. Ms. Bayliss and Ms. Giamporcaro are members of the Clinical Research Department at Allergan Medical Optics. Dr. Steinert is a consultant to Allergan Medical Optics. Journal of Cataract & Refractive Surgery: May 1995 - Volume 21 - Issue 3 - p 331-338 doi: 10.1016/S0886-3350(13)80143-5 Free Metrics Abstract The AMO® PhacoFlex® Model SI-18 was the first commercially available three-piece silicone intraocular lens (IOL) for use in small incision cataract surgery. Allergan Medical Optics’ silicone IOLs have been implanted in more than 750,000 patients worldwide over the past eight years. This report of the FDA clinical investigation of the AMO PhacoFlex model SI-18 IOL summarizes one year follow-up data from the initial premarket approval clinical trial on 500 core patients implanted with the SI-18 lens. One-year follow-up data from 5,860 patients in the modified core group and three-year follow-up data on the 500 patient core/modified core group are also presented. At three years postoperatively, 91.3% of best case core/modified core patients achieved 20/40 or better corrected visual acuity. Overall incidence of persistent complications at three years was 3.2%. © Williams & Wilkins 1995. All Rights Reserved.