 |
 | Home | Contact Us | FAQ | Search & Site Map | Link to Us |
 | Sign In | Join | Other 45 Sites in Network |
Medical Forum / General / Vision / September 2007Myopter inquiry w/ FDA
In response to my inquiry of Sept 7,: Questions/Comments: Is there a way to find out if the Myopter, shown at http://www.i-care.net/myopter.htm, is a medical device, and whether its met its regulatory standards? Today I had waiting for me: 9/18/07 Dear Mr. S******: In response to your inquiry below, I checked our databases, and found that we have not approved the Myopter. See: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm Due to our confidentiality concerns, we are unable to provide any information about a product before it is approved. You may want to contact the manufacturer, who may be willing to give you a status. Their website appears to make a medical claim. We will forward it to our Office of Compliance for possible follow-up. I hope this is helpful. Sincerely, B******** Public Health Advisor Consumer Assistance Staff Center for Devices and Radiological Health U.S. Food and Drug Administration (FDA  SignatureScott Reverse name to reply Hi, The product description states that: >The Myopter viewer is designed to solve the problem of excessive close work. Granted US Patent 3,883,225 it converts close work into distant work by eliminating >accommodation (focusing), convergence and stereopsis (3-D effect). This eliminates a major cause of myopia entirely and may occasionally IMPROVE the vision of >myopic children! But how do they know that near work even causes myopia, at all? Let alone improve the sight? The fact is, stupid new instruments like this absolutely disgust me, just look at how the poor child in the picture on the link is straining to see and squinting away! (http://www.i-care.net/ myopter.htm) The instrument if anything, will cause further damage to the sight of children and close-workers. The only intelligent solution is to learn to look at the near point with central fixation and thus without straining to see. What are these idiot developers going to come up with next. Previous link was broken, I meant this picture: http://www.i-care.net/myopterinuse.jpg Just look at how that poor child is straining and miserable and made very uncomfortable. Instruments like these, if worned for prolonged periods, I think they will be destructive to the vision. Let alone will they ever improve the sight, of myopia children. It is almost like the child is being shackled to chains, on the head. This is just a depressing kind of picture to look at... > children and close-workers. The only intelligent solution is to learn > to look at the near point with central fixation and thus without > straining to see. You can not define "central fixation" and "strain." If you can not define central fixation in real terms, it is not science. It is magic, mysticism. You say it is science. Your teachers will not. Rishi says your teachers are idiots. Rishi and Bates use broken thinking. You should learn to think better than Rishi and Bates. -MT Hi, central fixation means seeing one part best. Strain is a feeling that you become aware of. Its hard for me to define, but you know what it is when you begin rest methods. When you become aware of it, then the cure becomes easier. Rishi is not in contact with me, any longer. I do not talk to him. Rishi never said anything about teachers being idiots, except for the Bates teachers who corrupt the original system and are of course very very big idiots! You should learn to think for yourself. Sorry. Rishi Giovanni Gatti (Zetsu), Lena102938, and Otis Brown are trolls who haunt s.m.v. Otis is pathologically dishonest and actually hurts people. Following his advice can induce double vision in those not working with an eye doctor. Lena102938 uses anti-eye doctor rhetoric as a substitute for any actual information. It seems she now has to wear glasses and has developed a pathological (and ILLOGICAL) resentment toward the industry that "foisted these glasses upon her." You'd do well to ignore them and wait for responses from the caring, compassionate eye doctors who DO also participate in this site. Dear Lena, SUubject: Brooks is pathologically dishonest concerning the science of the natural eye's dynamic behavior. (And issue for thoughtful science -- not medicine. Make your own judgment accordingly. Prevention, at least, can not be "delivered" as a "medical product".) Brooks> Otis is pathologically dishonest and actually hurts people. Otis> Layman Brook's OPINION. Brooks> Following his advice can induce double vision in those not working with an eye doctor. Otis> As I have recommended MANY TIMES -- find a PREVENTION-MINDED optometrist like Steve Leung OD at: www.chinamyopia.org and work with him. Accept his recommendation to use the plus CORRECTLY. Understand and do what he recommends. But make this choice BEFORE you begin wearing that wretched minus lens. Understand yourself -- and your own motivations. Understand the majority-opinion attitude presented here -- and accept that there is an "educational process" associated with this PREVENTIVE second-opinion. Learn to be mature and wise about these issues. Understand that some problems require and accurate preception of the fundamental eye as a sophisticated system -- as a matter of scientific truth. Try to ignore the foul-mouthed poster here -- who has no training to judge the issues raised here. Second-opinion best, Otis > Sorry. Rishi Giovanni Gatti (Zetsu), Lena102938, and Otis Brown are > trolls who haunt s.m.v. Otis is pathologically [quoted text clipped - 10 lines] > responses from the caring, compassionate eye doctors who > DO also participate in this site. On Sep 18, 7:56 am, "otisbr...@pa.net" <otisbr...@pa.net> wrote: > Dear Lena, If you wish to correspond directly with Lena, perhaps you should e- mail her. THIS is a public forum. > SUubject: Brooks is pathologically dishonest concerning > the science of the natural eye's dynamic behavior. Having never spoken or written about it, that's just another flat- assed lie by Otis Brown. Nobody here discusses that but you, Otis. Nobody. > Brooks> Otis is pathologically > dishonest and actually hurts people. > > Otis> Layman Brook's OPINION. Fact. Readily verifiable fact. You're a pathological liar and a f.cking idiot. More fact. Readily verifiable fact. Hi Mr.Brooks, >Sorry. Rishi Giovanni Gatti (Zetsu), Lena102938, and Otis Brown are >trolls who haunt s.m.v. Otis is pathologically >dishonest and actually hurts people. Following his advice >can induce double vision in those not working with an eye doctor. I'm not sure, but I think Alex answered this on his website. If someone actually read the book from Otis, they would have read the chapter with the information about the dangers of use of plus lens, and how to prevent it from developing double vision. So, if someone does actually follow his advice and reads the book, chinamyopia etc, they would have effectively been 'warned'. >> Otis> Layman Brook's OPINION. >Fact. Readily verifiable fact. Umm, what kind of facts are you writing? You shoud at least get your 'facts' right, if you want to call them facts at all. I am not Rishi, so stop implying that I am. >In response to my inquiry of Sept 7,: > [quoted text clipped - 31 lines] > and Radiological Health >U.S. Food and Drug Administration (FDA Nice going. http://www.i-care.net/myopter.htm I suspect there's a Playboy magazine behind that book. It's the only way I'd let my picture go all over the web wearing that thing. Robert Martellaro ~~~~~~~~~~~~~~~~~~ Optician/Owner Roberts Optical Wauwatosa Wi. ~~~~~~~~~~~~~~~~~~ "Science is a way of trying not to fool yourself." - Richard Feynman Dear Scott, Subject: The Myopter is "Grandfathered". Otis> The Myopter does not need approval from the FDA because it was put on the market before the FDA started regulating devices. Otis> Same thing for minus lenses. Otis> Same thing for toothbrushes. (Who knows, mabybe toothbrushes CAUSE bad gums???) I think Layman Babbling-Brooks is attempting to make that kind of "case". Otis> Same thing for plus-readers sold in stores. Otis> Same thing for Snellen charts. Best, Otis > In response to my inquiry of Sept 7,: > [quoted text clipped - 34 lines] > Scott > Reverse name to reply > Otis> The Myopter does not need approval from the FDA because it was > put on the market before the FDA started regulating devices. Well, not quite. Only pre-1976 FDA Class III devices are grandfathered, and even then, they can only be legally marketed until the FDA requests safety and efficacy data and the manufacturer fails to provide it, or the supplied data fail to demonstrate safety and efficacy. Here's hoping the FDA gets around to requesting the data now that their Compliance Office is hot on the trail. I'm sure your buddy will enjoy getting his call from the FDA. If it happens, you can tell him its because of the attention to the site you've been generating, Otis. SignatureScott Reverse name to reply > "otisbr...@pa.net" <otisbr...@pa.net> wrote innews:1190135832.340255.148100@w3g2000hsg.googlegroups.com: > [quoted text clipped - 17 lines] > Scott > Reverse name to reply You are on the mission to reveal truth for consumers ? It looks very nice. I wonder why they decided to call it 'myopter', in the first place. It sounds a bit weird, I mean like something that would induce myopia, instead of something which would reduce it. You know what I mean? I mean they should have thought of a better name, like: Myophealer, or Myopcurer, or something. But come on, what kind of a name is 'Myopter'! On Sep 18, 11:11 am, Scott Seidman <namdiestt...@mindspring.com> wrote: > Here's hoping the FDA gets around to requesting the data now that their > Compliance Office is hot on the trail. > > I'm sure your buddy will enjoy getting his call from the FDA. If it > happens, you can tell him its because of the attention to the site you've > been generating, Otis. Thank you, Scott. Good luck, Uncle Otie. Let us know when whether or not you receive Rehm's Christmas card on time this year. |
Reply to this Message |
 Sign In
 Join
 My Latest Posts My Monitored Threads My Blog My Photo Gallery My Profile My Homepage Start New Thread Enable EMail Alerts Rate this Thread
|
©2008 Advenet LLC Privacy Policy - Terms of Use
This website includes both content owned or controlled by Advenet as well as content owned or controlled by third parties.