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Update report on intraocular lenses

D M Worthen, J A Boucher, J Buxton

    Ophthalmology
    |May 1, 1981
    PubMed
    Summary
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    The Food and Drug Administration (FDA) has regulated intraocular lenses since 1978. Legal actions have delayed the release of study results and premarket approval for these medical devices.

    Area of Science:

    • Ophthalmology
    • Medical Device Regulation
    • Public Health Policy

    Background:

    • Intraocular lenses (IOLs) have been subject to Food and Drug Administration (FDA) regulation since 1978.
    • Over 177,000 IOLs across four classes were implanted by August 1979.
    • Public interest and legal challenges have impacted the regulatory process.

    Purpose of the Study:

    • To outline the interactions between stakeholders regarding intraocular lens regulation.
    • To detail the events leading to the re-examination of FDA's IOL study.
    • To explain the delays in premarket approval and public release of findings.

    Main Methods:

    • Review of regulatory history and legal actions concerning intraocular lenses.
    • Analysis of the Food and Drug Administration's study on intraocular lenses.

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  • Chronological documentation of events and stakeholder interactions.

    • Main Results:

    • Regulatory scrutiny and legal challenges have led to a re-evaluation of intraocular lenses.
    • The FDA study on intraocular lenses faced delays in premarket approval.
    • Public release of study results was prohibited due to ongoing legal actions.

    Conclusions:

    • The case highlights complex interactions between regulatory bodies, manufacturers, medical professionals, and consumer advocacy groups.
    • Legal and public health advocacy can significantly influence medical device regulation and approval processes.
    • Delays in regulatory processes can impact the availability and public knowledge of medical device study outcomes.