Exposing the LASIK Scam

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 Post subject: Report your bad outcome to the FDA!
PostPosted: Sun Aug 05, 2007 9:29 pm 
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The FDA has a program in place called MedWatch.

What is MedWatch?

From the FDA website:
Quote:
FDA has the responsibility for assuring the safety and efficacy of all regulated marketed medical products.

MedWatch, The FDA Safety Information and Adverse Event Reporting Program, serves both healthcare professionals and the medical product-using public. We provide important and timely clinical information about safety issues involving medical products, including prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements and infant formulas).

Medical product safety alerts, recalls, withdrawals, and important labeling changes that may affect the health of all Americans are quickly disseminated to the medical community and the general public via this web site and the MedWatch E-list. Select Safety Information to see reports, safety notifications, and labeling changes posted to the website since 1996.

MedWatch allows healthcare professionals and consumers to report serious problems that they suspect are associated with the drugs and medical devices they prescribe, dispense, or use. Reporting can be done on line, by phone, or by submitting the MedWatch 3500 form by mail or fax. Select How to Report for more details.


From the FDA website:
Quote:
After you submit a MedWatch form, FDA will review your information, along with other reports, to determine how serious and widespread the problem is.


The problem with MedWatch is that almost no one knows about it, so most patients with bad outcomes never report. And don't hold your breath waiting for your doctor to report your bad outcome.

If you want the FDA to know "how serious and widespread the problem is", it is imperative that you report your bad outcome.

If you've been wondering how you can help or what you can do, this is it. If every LASIK patient who had a bad outcome filed a MedWatch report, the FDA would be flooded with adverse events reports. These reports are available online by searching this link:

http://www.accessdata.fda.gov/scripts/c ... search.cfm

Type in LZS for lasers, or HNO for microkeratomes in the Product Code field. For Intralase, type Intralase in the Manufacturer field. To narrow your search to a particular laser brand, type that information in the Brand Name field. Be sure to set the search dates.

Tell the FDA about your bad outcome. Use this link to file your MedWatch report:
https://www.accessdata.fda.gov/scripts/ ... online.htm

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject:
PostPosted: Sun Oct 21, 2007 8:33 pm 
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From the FDA website:

Quote:
Q: How do I report a bad experience or who do I notify about a 'bad' doctor?

A: If you had a bad experience or sustained an injury, you should file a voluntary MedWatch report (1-800-FDA-1088) to the FDA. Also, you could contact your state medical licensing board and file a complaint with them. In addition, you could contact your state health department or consumer complaint organization (e.g., Better Business Bureau).


http://www.fda.gov/cdrh/lasik/faq.htm#2

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Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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 Post subject:
PostPosted: Sat May 31, 2008 1:42 pm 
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FDA has recently updated its LASIK webpage with a link directly to the MedWatch online reporting form.

http://www.fda.gov/cdrh/lasik/reporting.htm

Kudos to the advocate who petitioned the FDA persistently to make this important change to the website in order to more effectively communicate to patients how to report a bad outcome from LASIK to the FDA.

Another victory for patients! :)

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"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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