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.