The 20/20 Editorial Team

James J. Spina
VP, Editor-in-Chief

Jacqueline Micucci
Executive Editor

Gloria Nicola
Senior Features Editor

Andy Karp
Group Editor, Lenses and Technology

Melissa Arkin
Assistant Editor

Lauren Taylor
Editorial Assistant

2/19/2008 Let’s Get Rolling on Drop Balling
Posted by 20/20&U Blog Admin
Location: Blogs2020&U
 		    
The Food and Drug Administration’s recent proposal to impose new guidelines for lens impact testing is sending shock waves throughout the optical industry. Lens manufacturers, makers of in-office edging equipment, optical laboratories, eyecare professionals and, ultimately, consumers, could be significantly affected if FDA adopts the guidelines. What’s at stake is whether or not eyecare professionals will be able to continue edging lenses in their in-office labs without incurring liability if a patient is injured by a broken lens.

The situation is complex, and made even more so by the confusing language in the FDA proposal, which is known as the Draft Guidance on Impact-Resistant Lenses with Questions and Answers. However, a key issue centers around data obtained by FDA that indicates that every lens that is drop ball tested is damaged in some way. Based on this information, FDA is suggesting that no lens tested be sold for wear.

FDA is continuing to accept comments on its draft Q&A. I urge readers to let FDA know how you feel about this important issue. Send your comments to www.fda.gov/dockets/ecomments. All comments should be identified with docket number fr26oc07-.76.

Share your comments with other 20/20 readers by posting them to this blog. Tell us how the FDA’s proposed guidelines would affect your practice or business. Now is the time to speak up. Let’s not drop the ball on drop balling.

—Andrew Karp
Group Editor, Lenses and Technology
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Comments (6)   Add Comment
Re: Let’s Get Rolling on Drop Balling
By Jon Nitardy		 2/21/2008
s
Eye care professionals cannot allow this to go through. Please visit the fda website and post your comments.

Jon Nitardy OD
Re: Let’s Get Rolling on Drop Balling; student
By william m. parker		 2/21/2008
s
sir;
if the government wants to change the standards--we should try to get optical individuals on board with the fda.
Re: Let’s Get Rolling on Drop Balling
By Steve Ross		 2/22/2008
s
The drop-ball test is a destructive test. Surely, 2008 standards in lens production quality and known impact results for all lens materials could/should move us away from this antiquity. Has the OLA gotten involved?
The FDA impact standard is obsolete anyway
By Barry Santini		 2/22/2008
s
It was formulated when eyeglasses were 80% dispensed with untempered glass lenses. There really is no reasonable, cost-benefit impact health risk to the American public with the eyewear delivered today. In fact, I'l submit there is far greater risk with *glass* polarized plano sunwear than any Rx eyewear on the market.
The only reason eyewear is overseen by the FDA is 'cause it was classed as a *medical* device by them in 1972. Today, this classification category in a prison from which we need to free eyewear, in order to let it enjoy true fashion status.
Re: Let’s Get Rolling on Drop Balling
By FEFE5AA6-F10C-4435-917C-79ADEEFA7230		 2/22/2008
s
Has the OLA gotten involved on this issue?
Re: Let’s Get Rolling on Drop Balling
By Leo Hadley Jr.		 2/25/2008
s
Even if some sort of law was passed, all you would need is a $100 drop ball tester and a log book. I do oppose this legislation because there is no way anyone could be held liable if a consumer gets hit in the eye with a baseball bat. Should the frame manufacturer be held liable? The Optician who made and dispensed the lenses? Or the guy with the baseball bat? Its ridiculous that anyone could be held liable for circumstances that can happen outside the normal use of eyewear.
This legislation has NO CHANCE.

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