Article Date: 2/1/2011

An Update on Regulatory Changes for Lens Care Systems
Contact Lens Care & Compliance

An Update on Regulatory Changes for Lens Care Systems

By Susan J. Gromacki, OD, MS, FAAO

On his “Top Ten List of Lens-Related Topics for 2010” (September 2010 Editor's Perspective), Contact Lens Spectrum Editor Dr. Jason Nichols listed as #2 (in no particular order): “Care solutions—forthcoming regulatory changes.” Although the United States Food and Drug Administration (FDA) has not yet announced new guidance recommendations regarding the testing of multipurpose contact lens care products, the agency has been hard at work. At the American Academy of Optometry Annual Meeting in November, 2010, I met with Jim Saviola, OD, of the FDA's Center for Devices and Radiological Health, who provided me an update of the agency's activities.

Recent FDA Activity on Lens Care Regulation

First, the FDA issued a guidance document on Aug. 15, 2010, addressing contact lens care products' labeling recommendations. One recommendation, which is consistent with several professional eyecare organizations, was that manufacturers of contact lens multipurpose solution products remove the “no rub” from product labeling and stress the importance of “rubbing and rinsing” in caring for contact lenses. The FDA-recognized International Organization for Standardization (ISO) stand alone testing requirements for contact lens care products utilize a contact lens solution and test organism—but no contact lenses or case—at the present time. To this end, a project group within the ISO ophthalmic subcommittee has been commissioned to augment the current testing. Five laboratories are currently completing a “ring test” of a new methodology and will look to publish their results soon.

Acanthamoeba Testing

In addition, current ISO standards do not require testing against Acanthamoeba. The FDA's Ophthalmic Devices Advisory Panel, meanwhile, recommended adding Acanthamoeba as a test organism at its meeting in June 2008. Following the FDA-convened Microbiological Testing of Contact Lens Care Products Workshop in January 2009, an FDA scientist has been comparing different published methods of growing, harvesting, and forming cysts of Acanthamoeba to eventually accomplish the goal of utilizing it as a test organism.

New Group for Silicone Hydrogel Materials

Next, the FDA—along with the ISO and American National Standards Institute—has established a Group 5 classification for silicone hydrogel materials. FDA scientists are currently studying different silicone hydrogel material properties to provide data on how to subdivide the group appropriately. Their goals are to have this information available for ISO meetings in May, 2011 and to publish this information in a peer-reviewed journal.

More to Come

So stay tuned in 2011; this will be an exciting new year in the area of contact lens care products. CLS

To obtain references for this article, please visit http://www.clspectrum.com/references.asp and click on document #183.


Dr. Gromacki is a Diplomate in the Cornea, Contact Lenses, and Refractive Technologies section of the American Academy of Optometry. She is chief research optometrist at Keller Community Hospital in West Point, N.Y.

Contact Lens Spectrum, Issue: February 2011