http://www.fda.gov/ohrms/dockets/ac/03/ ... 3991t1.htm
DR. BRADLEY: Also, Jayne, the suggestion was made that implantable contact lens be that name be changed presumably in the device.
DR. WEISS: Well, I understood from the agency that that's not something that we would get involved in. Ralph, are we getting involved in names? I guess we're not getting involved in names.
DR. ROSENTHAL: You can recommend whatever you'd like to recommend, and we will
DR. WEISS: So what is that
DR. ROSENTHAL: act accordingly if we feel that
DR. WEISS: What would you like to say specifically as far as that goes?
DR. BRADLEY: I think it should be described to the patient in an accurate way, and if the FDA deems that contact lens is misleading, which some of us on the panel believe, then that should be changed.
DR. WEISS: So we could have a better description of what is meant in this case of a contact lens in the labeling. I don't know if we list it, but we should list that the effect of pupil size is not known. I think I mentioned that. I did mention that. Dr. McMahon.
DR. McMAHON: I think the intent of the comment was, is not to explain what a contact lens is, but that the word "contact lens" is misrepresentative of what this device is. And the panel recommends that that term be eliminated from the title of the device, and from labeling.
DR. WEISS: I think the does the panel sort of is there consensus on that statement? I see head nods which will so there's consensus that this that wording is deceptive, and we would leave it up to the FDA to come up with better wording.
