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editor's perspective
The Contact Lens Event of 2006
BY
JOSEPH T. BARR, OD, MS, FAAO, EDITOR
There's never been a more controversial or profound
event in the history of contact lens care than the global recall and discontinuation
of manufacturing and sales of ReNu with MoistureLoc by Bausch & Lomb. What had
become the most successful launch of a new product in the history of contact lens
solutions, and a solution that truly did make silicone hydrogel lenses more wettable
clinically, ended with a spike in Fusarium infections and a legal nightmare
for many. But that is past and we've all been sobered and reminded in no uncertain
terms about the importance of safe, biocompatible, well-tested contact lens care
products, and how they protect and help our patients succeed in contact lens wear.
In
other contact lens events, one common controversy in 2006 was whether the corneal
staining that seems to be induced by some contact lens solutions more than others
and with some lenses more than others is very important or not so important. Beyond
the measurement complications, it seems at this point that the companies whose products
don't seem to induce as much staining promote that the staining is highly important,
while the companies whose products may cause more staining are more eager to attack
the methods used in the staining studies.
In late 2006, The U.S. Food and Drug Administration (FDA) issued
a guidance on decorative, non-corrective contact lenses. Although the FDA calls
this guidance a less burdensome approach and it doesn't bind the FDA, it makes some
strong statements. In discussing risks of contact lens wear, the guidance states
that risks can't be sufficiently controlled unless the wearer does the following
under professional supervision: Obtains advice about using contact lenses; has a
valid prescription; has the lenses fit properly; and remains under appropriate professional
care for contact lenses. Can manufacturers, importers, distributors or retailers
market decorative lenses over the counter? "No," says the FDA! Are these people
subject to inspection by the FDA? "Yes," says the FDA! How are imported lenses affected
by the FDA's law? As devices (and not cosmetics), lenses that don't comply with
prescription device rules and without premarket authorization are considered adulterated
and misbranded. Hurray for the FDA!
I would have preferred if the event of the year was the rapid
growth of silicone hydrogel lens prescribing and clinical success. We'll even have
a lathe-cut custom-made silicone hydrogel in 2007. This is an amazing event, to
be sure.
Will 2007 be the year that legislative efforts (see p. 32) result
in a further loosening of availability of contact lenses from alternative suppliers
or will the Fairness to Contact Lens Consumers Act be left untouched or bolstered
(see p. 33)? Stay tuned.
Contact Lens Spectrum, Issue: January 2007