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Medical Devices

Public Workshop – Revamping Microbiological Test Methods for Contact Lenses, Products and Accessories to Protect Health and Ensure Safety, September 12, 2014.

The Food and Drug Administration (FDA), American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOpt), American Optometric Association (AOA), and Contact Lens Association of Ophthalmologists, Inc. (CLAO) are co-sponsoring the following workshop entitled “Revamping Microbiological Test Methods for Contact Lenses, Products and Accessories to Protect Health and Ensure Safety.” The purpose of this workshop is to discuss adequate testing of contact lens care products for disinfection efficacy against emerging pathogens as well as common infectious etiologies.

Date, Time and Location:

This meeting will be held September 12, 2014, beginning at 8:00 am – 5:00 pm at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

FDA Campus Information


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TimeAgenda ItemSpeaker
8:00am-8:05amWelcome & Goals – Food and Drug Administration (FDA)Malvina Eydelman, MD
8:05am-8:10amWelcome – American Academy of Ophthalmology (AAO)Thomas Steinemann, MD
8:10am-8:15amWelcome – American Academy of Optometry (AAOpt)Loretta Szczotka-Flynn, OD
8:15am-8:20amWelcome – American Optometric Association (AOA)Joseph Shovlin, OD
8:20am-8:25amWelcome – Contact Lens Association of Ophthalmologists (CLAO)Deborah Jacobs, MD
8:25am-8:35amRegulation of Contact Lenses and Associated Care ProductsDenise Hampton, PhD (FDA)
8:35am-8:45amPreclinical Test Methods for Contact Lenses and their Care ProductsJeffrey Brocious, MS (FDA)
8:45am-8:55amHistory & Rationale for the Panel of Test Organisms for Contact Lens Care ProductsRalph Stone, PhD

Panel 1: Emerging Pathogens in Contact Lens-Related Keratitis

ModeratorLoretta Szczotka-Flynn, OD (AAO)
PANELISTSSuzi Fleiszig, OD, PhD, Michelle Callegan, PhD, Michael Gilmore, PhD, Mark Willcox, PhD, Eduardo Alfonso, MD, Jennifer Cope, MD, MPH (CDC), Jonathan Yoder, PhD (CDC), Elmer Tu, MD, John Dart, MD
8:55am-9:10amCauses of Contact Lens-Related Infectious Keratitis in the U.S.: Historical Trends and Emerging PathogensJonathan Yoder, PhD (CDC)
9:10am-9:25amInternational Patterns of Contact Lens- Related Infectious KeratitisJohn Dart, MD
9:25am-9:40amImpact of Changing Water Restrictions on Contact Lens-Related Infectious KeratitisElmer Tu, MD
9:40am-10:40amPanel Discussion Question #1

Panel 2: Role of Soil in Disinfection Efficacy Testing

Moderator Michael Duenas, OD (AOA)
PANELISTSCarol Lakkis, PhD, Suzi Fleiszig, OD, PhD, Michelle Callegan, PhD, Michael Gilmore, PhD, Mark Willcox, PhD, Ralph Stone, PhD
Definition of Organic Soil and the Relevant Components of an Artificial Tear Model Mark Willcox, PhD
11:10am-11:25amIncorporating Soil in the Preclinical Testing of Contact Lenses and their Products: Historical Perspective & Current MethodsScott Steffen, PhD (FDA)
11:25am-11:40amMeasuring the Efficacy of Organic Soil RemovalJoseph Hutter, PhD (FDA)
11:40am-12:40pmPanel Discussion Question #2

Panel 3: Acanthamoeba:  The Organism and Test Methods

Moderator Deepinder Dhaliwal, MD (CLAO)
PANELISTSDonald Ahearn, PhD, Simon Kilvington, PhD, Elmer Tu, MD, Ralph Stone, PhD, Mary Mowrey-McKee, PhD
1:40pm-1:55pmAcanthamoeba Keratitis: Biology of the Organism and Host FactorsDonald Ahearn, PhD
1:55pm-2:10pmDisinfection Efficacy Test Methods for AcanthamoebaDaniel Fedorko, PhD (FDA)
2:10pm-2:25pm Disinfection Efficacy Test Methods for AcanthamoebaSimon Kilvington, PhD
2:25pm-4:25pmPanel Discussion Questions #3-5
4:25pm-5:00pmClosing Remarks
CLAODeepinder Dhaliwal, MD
AOAJoseph Shovlin, OD
AAOpLoretta Szczotka-Flynn, OD
AAOThomas Steinemann, MD
FDAMalvina Eydelman, MD

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Registration to Attend the Workshop:

To register for the public workshop, please visit Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. If there are any questions with registration, please contact Ms. Cindy Groff at Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list.

Registration is $250 for members of the American Academy of Ophthalmology (AAO), American Academy of Optometry (AAOpt), American Optometric Association(AOA), or Contact Lens Association of Ophthalmologists, Inc. (CLAO); or $400 for non-members and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online. The deadline for online registration is September 5, 2014 at 4:00 PM EDT. There will be no onsite registration on the day of the public workshop.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661,

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Contact Us

For questions regarding workshop content please contact:

Jeffrey Brocious, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, Phone: 240-402-3797, email:

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