With the introduction of any new technology comes the subsequent barrage of complications that we previously never considered. From new materials to new chemical compounds in solutions, the last two decades have brought in the good, and the bad. As a result, in 1997, the FDA—which regulates Class II (moderate risk) medical devices, such as contact lenses—issued a “Premarket notification (510(k)) guidance document for contact lenses,” which outlined the necessary information on solution safety and efficacy needed by the FDA to evaluate a solution for market clearance.1 In addition to working with industry on marketing, the FDA approves all package labeling to inform consumers of the appropriate use and potential risks of lens care products (solution packaging, package insert and solution bottle). As a final step to ensure consumer safety, the FDA maintains a consumer-oriented website to emphasize the importance of proper lens care.2
However, since that first guidance document, the contact lens care market has changed. It now is predominantly composed of multipurpose solutions (MPSs). However, MPSs reportedly have a very high rate (79%) of noncompliance to labelled instructions, including topping off.3
In 2006 and 2007, there were microbial keratitis outbreaks that were determined to be solution-related. In response, the FDA held a two-day workshop in January 2009 to reach a consensus on the testing methods for evaluating contact lens products against Acanthamoeba and to discuss critical elements for a modified disinfection efficacy test to better simulate real world conditions.4 The FDA decided to sponsor independent research and those findings were published in November 2012.5
MPS vs. Silicone Hydrogels
MPSs are a complex mixture of preservatives, disinfectants, surfactants, buffers and other chemicals designed to clean and disinfect a contact lens, while not altering the contact lens and remaining neutral on the eye. The FDA developed classifications of hydrophilic contact lens materials (Group 1 through Group 4) based on iconicity and water content, so that solutions could be systematically tested for lens alterations.
Silicone hydrogel materials have significantly different lens surface characteristics than hydrogel materials, including wettability and deposition of proteins and lipids. These differences in materials could lead to very different lens solution interactions, such as biofilm formation on the lens or lens case, changes in preservative or biocide efficacy, or biocide sequestration. The FDA evaluated these variances and proposed a new material grouping system of silicone hydrogel lenses for solution testing.6
Solutions vs. Pathogens
Arguments have been made that the combination of lack of “real world” testing, changes in solutions and lens material, patient noncompliance, and the emergence of new pathogens led to the outbreaks of Fusarium (2006) and Acanthamoeba (2007), which resulted in the voluntary removal of lens care products from the market. As a result, starting in 2008, the FDA undertook a large-scale review of lens care products and the factors involving these pathogen outbreaks. It was determined that how organisms are cultured and the methods used to encyst the Acanthamoeba do affect the outcome of solution testing. Both of these criteria, and the need to address multiple strains, were proposed in the new protocol for testing microbial efficacy.
To support the safe use of lens care products, the FDA has developed a comprehensive research plan to improve testing of contact lenses and solutions. This plan includes evaluating the physiochemical properties of silicone hydrogel lenses, examining the antimicrobial effectiveness of a solution, determining the preservative/biocide depletion in the presence of a contact lens in real world scenarios, and adding Acanthamoeba as a test organism.5
In addition, the FDA has changed the direct-to-consumer messaging by developing a website, with supporting audio and video, on proper lens care. They also have started increasing the guidance provided to the industry on product labeling, including instructions to remove the “no-rub” from packaging and to provide a timeframe for when to discard open products.5
The next few columns will delve into the new FDA guidelines.
1. Premarket notification (510(k)) guidance document for contact lenses. FDA. Available at:
www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080218.pdf. Accessed February 20, 2013.
2. Focusing on contact lens safety. FDA. Available at: www.fda.gov/forconsumers/consumerupdates/ucm048893.htm. Accessed February 2013.
3. de Oliveira PR, Temporini-Nastari ER, Ruiz Alves M, Kara-José N. Self-evaluation of contact lens wearing and care by college students and health care workers. Eye Contact Lens. 2003 Jul;29(3):164-7.
4. Joint workshop on microbiological testing for contact lens care products. FDA. 2009 Jan. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ssLINK/ucm111136.htm. Accessed February 2013.
4. Eydelman M, Tarver M, Kiang T, et al. The Food and Drug Administration’s role in establishing and maintaining safeguards for contact lenses and contact lens care products. Eye Contact Lens. 2012 Nov;38(6):346-9.
5. Hutter J, Green JA, Eydelman M. Proposed silicone hydrogel contact lens grouping system for lens care product compatibility testing. Eye Contact Lens. 2012 Nov;38(6):358-62.