FDA study of intraocular lenses.
The frequency of intraocular lens implantation in the United States has increased dramatically despite Federal regulation. Legal challenges prevented previous release of information. Data collected during the first two years of the FDA study reflect relative safety and effectiveness. Information on over 400,000 implantations reveals a low incidence of adverse reactions (average 1.94%) and visual results equal to or better than control cases (78% 20/40 or better). Future reports will not reflect the same data base, since adjunct information and information on approved lenses will no longer be available.
D004869:Equipment Safety; D005128:Eye Diseases / Q000209:etiology; D006801:Humans; D007910:Lenses, Intraocular / Q000009:adverse effects* / Q000592:standards; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration; D014792:Visual Acuity