FDA Panel Hears Recommendations on Contact Lens Solutions

From Contact Lens Today, a newsletter of Contact Lens Spectrum.

The Food and Drug Administration (FDA) Ophthalmic Devices Panel of the Medical Devices Advisory Committee met on June 10, 2008 to consider recommendations on contact lens product development including preclinical testing and clinical performance measures, and labeling for contact lenses and lens care products.

Among the issues reviewed were:

• Changes from “no rub" to “rub and rinse” labeling
• Addition of "discard dates" on contact lenses to indicate when a product should be disposed of after it's opened
• Expanding preclinical testing protocols to include testing solutions against more types of bacteria and fungi including Acanthamoeba
• Recommendations on frequent replacement of contact lens cases
• Stronger warnings against reuse of contact lens solutions

The panel also considered information offered by companies and others such a joint statement issued by The American Academy of Ophthalmology, the Contact Lens Association of Ophthalmologists, the Cornea Society and the American Society of Cataract and Refractive Surgery. A complete text of their recommendations is available at: http://aao.org/upload/joint_CL_recommendationsL.pdf. Representatives of the American Academy of Optometry Section on Cornea and Contact Lenses and the American Optometric Association Contact Lens and Cornea Section also addressed the panel.

Nathan Bonilla-Warford, OD
Bright Eyes Family Vision Care
Located in the Westchase area of Tampa.