http://www.fda.gov/CDRH/contactlenses/types.html#rgp
http://www.fda.gov/fdac/features/1998/298_lens.html
“The vision correction effect is temporary. If Ortho-K is discontinued, the corneas will return to their original curvature and the eye to its original amount of nearsightedness. Ortho-K lenses must continue to be worn every night or on some other prescribed maintenance schedule in order to maintain the treatment effect. Your eye care professional will determine the best maintenance schedule for you.”
On above statement, FDA says "the corneas will return to their original curvature and the eye to its original amount of nearsightedness."
Based the reading from the site and other sites, this statement is untrue because the ortho-k can persistently reduced the thickness of the cornea and caused the persistent corneal shape change. Here I use "persistent" because there is no way to approve this is permanent because the patients can not wait for a life time (they may wait 6 month or a year) and they have to use other surgery to fix the problem that occurred after wearing the Ortho-K.
I also am confused where FDA gets such statement because I read several package insert, the companies never this way although I can the same statement from the media or newspaper.
So, what we should do? This already caused the misleading and the misleading caused eye injure (people believed such statement and wore such lens; finally the cornea thickness became thinner lower than normal and also the corneal shape changed irregularly).
We can file a complaint on FDA Medwatch for the company problem. For FDA own problem, what we should do?
This discussion is related to
Vision Shaping Treatment - when and why?.