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Photo by Lee Snyder.

WASHINGTON—A coalition of eight optical groups joined together last week and submitted recommendations to the Food and Drug Administration (FDA) regarding the FDA’s proposed changes to lens impact testing guidelines.

The coalition included the American Academy of Ophthalmology, American Optometric Association, Opticians Association of America, Optical Laboratories Association, Sunglass Association of America, International Standard Organization TC 72/SC7, National Academy of Opticianry and The Vision Council. The group submitted recommendations to the FDA as a revised draft of the document titled “Impact-Resistant Lenses: Questions and Answers” released in October 2007 for public comment.

“We are very positive that the FDA is listening to us and the industry as a whole understood the importance of this issue and came together to respond,” said Ed Greene, CEO of the Vision Council.

According to the coalition, the revised draft aims to provide the safest lens for the consumer, with an emphasis on the following factors:

The need to provide testing guidelines which will ensure that safe impact resistant prescription lenses are provided to American eyeglass wearers.
Current lens technology.
The need to ensure that the guidelines in the document are consistent with 21 CFR 801.410 (current impact-resistant lens regulation).
The need to eliminate guidelines that do not increase safety, but define procedures that add extra cost for the consumer, additional time to the completion of the prescription and burdensome costly procedures for the service provider.

View a PDF of the group’s revised draft of the document.

Comments from other optical industry organizations and independent eyecare professionals about the Food and Drug Administration’s controversial proposed guidelines for eyeglass lens impact testing. The comments, which were submitted to the FDA over the past few months, are mostly opposed to the FDA's planned changes in the guidelines. Many reflect the view that the new guidelines would hamper the delivery of eyewear while providing no additional safety for consumers.