The FDA Report on Intraocular Lenses

Walter J. Stark, David M. Worthen, Jack T. Holladay, Patricia E. Bath, Mary E. Jacobs, George C. Murray, Eleanor T. McGhee, Max W. Talbott, Melvin D. Shipp, Nancy E. Thomas, Roger W. Barnes, Daniel W.C. Brown, Jorge N. Buxton, Robert D. Reinecke, Chang Sheng Lao, Scarlett Fisher

Research output: Contribution to journalArticle

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 February 9, 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 the posterior chamber and anterior chamber IOLs.

Original languageEnglish (US)
Pages (from-to)311-317
Number of pages7
JournalOphthalmology
Volume90
Issue number4
DOIs
StatePublished - Jan 1 1983

Keywords

  • U.S. Food and Drug Administration (FDA)
  • cataract
  • intraocular lenses
  • pseudophakos

ASJC Scopus subject areas

  • Ophthalmology

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    Stark, W. J., Worthen, D. M., Holladay, J. T., Bath, P. E., Jacobs, M. E., Murray, G. C., McGhee, E. T., Talbott, M. W., Shipp, M. D., Thomas, N. E., Barnes, R. W., Brown, D. W. C., Buxton, J. N., Reinecke, R. D., Lao, C. S., & Fisher, S. (1983). The FDA Report on Intraocular Lenses. Ophthalmology, 90(4), 311-317. https://doi.org/10.1016/S0161-6420(83)34555-3