LONG-TERM CLINICAL-RESULTS OF AMO PHACOFLEX MODEL SI-18 INTRAOCULAR-LENS IMPLANTATION

The AMO (R) PhacoFlex (R) Model SI-18 was the first commercially avail able three-piece silicone intraocular lens (IOL) for use in small inci sion cataract surgery. Allergan Medical Optics' silicone IOLs have bee n implanted in more than 750,000 patients worldwide over the past eigh t years. This report of the FDA clinical investigation of the AMO Phac oFlex model SI-18 IOL summarizes one year follow-up data from the init ial premarket approval clinical trial on 500 core patients implanted w ith 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 postoperat ively, 91.3% of best case core/modified core patients achieved 20/40 o r better corrected visual acuity. Overall incidence of persistent comp lications at three years was 3.2%.