THE FDA REPORT ON INTRAOCULAR LENSES

Abstract

Clinical studies of intraocular lenses (IOLs) as investigational devices have been regulated in the United States by the Food and Drug Administration (FDA) since 9 February 1978. As of August 1982. data have been collected on more than one million IOLs implanted. During the last 12 months of the study, 409 000 IOLs were implanted. Visual acuity of 20/40 or better at one year after surgery was present in 85% of over 45 000 cases reviewed. Increasing patient age, surgical problems, postoperative complications, and adverse reactions were factors that reduced the visual acuity. The current trend in the USA is for implantation of posterior chamber and anterior chamber IOLs. Copyright © 1984, Wiley Blackwell. All rights reserved