Q&A Ask the Labs By Joseph L. Bruneni Q.
Muddy
Legal Waters A.
The problem dates back to the early '70s when the state of California passed a law stating that ANSI standards "currently in effect" would govern lens thickness. When the thickness requirement was later amended to the more sensible "performance" requirement (lenses can be processed to any thickness, as long as they pass the drop ball test), the state of California filed for an exemption to that FDA requirement. The Federal Government, in 1979-80, issued a ruling denying California an exemption to the FDA thickness requirement. A key factor in the establishment of a Federal Food and Drug Administration was to have Federal standards that superceded all state standards. Letting each state set its own requirements regarding medicines and medical devices (eyeglasses) would result in chaos. California's choice of the words "currently in effect" was also ambiguous. Did the legislators mean the ANSI standards currently in effect at the time the bill was signed into law, or did they mean the ANSI standards in effect any time after the bill was passed? It was a situation only lawyers could appreciate. Currently, since California did request an exemption to the FDA thickness regulation and was formally denied that exemption, doctors and dispensers in California can never be successfully prosecuted for dispensing glass lenses that comply with current FDA requirements, such as Clears� and Thin & Dark� lenses. Q.
Proving
Quality? A.
It was developed to answer concerns about stories appearing on news programs in which the networks sent out shoppers to purchase eyeglasses, which were then tested to national industry and ANSI standards. There have been nine television programs on this subject in the past year, as well as routine stories on eyewear in Consumer Reports. The newly developed optical program sends out secret shoppers to visit each participating office twice (or more) each year. They purchase eyeglasses, which are then sent with the prescription to a national testing lab for careful analysis. The shopper's report also investigates how patients are greeted, the selections available, speed of service, and fit and comfort of the final glasses. If the office meets certain quality standards, they receive an award that can be displayed in the office and featured in office publications or advertising. This quality assurance service is offered by Colts Laboratories. For additional information, check its Web site at [archive_results]?loc=archive/archive_results.asp?loc=archive/refresh/coltslab.htm" target="new"> www.colts-laboratories.com or call the company at 727-725-2323. Q.
Polycarbonate
for Children A.
The thicker 2.2mm stock lenses offered a viable choice for children's eyewear, but are no longer available. You might consider the reason thicker 2.2mm lenses were discontinued: they simply became superfluous because standard thickness 1.5 polycarbonate provided more than adequate protection for children's eyewear. Labs can still surface children's lenses to 2.2mm, but doing that slows delivery without contributing any meaningful added protection. EB Got a question you'd like answered in "Ask the Labs?" Send it now!
|
Article
Ask the Labs
Eyecare Business
June 1, 1999