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Dear all --
I'm eight years post-Lasik, still coping with night vision disturbances and dry eyes, and while I've done what I can talking to family and friends, worked with Rebecca on the website LaserMyEye, been a member here since this website started, and placed a front-page story on my local newspaper about my situation, I had never, ever, made such a report to the FDA.
I reproduce below YGB's message . . . because it is by now submerged in the thread about the FDA meeting on April 25th.
It took me about a half-hour to answer the questions, but only because I am chatty. Basically: what happened to you? what equipment was used? do you have objective evidence of your problem (dates, data/readouts/numbers)? what relevant history can you provide? (pre-existing conditions, etc.). You can skip items that don't apply, such as serial numbers of equipment, etc. At the very end you get to review your answers and have the opportunity to edit it all.
Thanks again to YGB, Lucy, Natalie06, and Rebecca for urging us to let our voices be heard!
mary (known to the "old-timers" as "gloomsburg" on SurgicalEyes)
===============================================
Here's what YGB posted:
No need for guilt. However, all LASIK sufferers should report their bad outcomes to the FDA. I posted this somewhere else, but here it is again ...
If we want the FDA to know "how serious and widespread the problem is", it is imperative that we report our bad outcomes to the FDA.
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. The web link below will take you to the "MedWatch Online Voluntary Reporting Form (3500)".
Then click on the BEGIN button to the right of the page. The Patient Identifier field can be left blank. On the next page, for #1 click on "Adverse Event", for #2 click "Disability or Permanent Damage" (assuming that is applicable to you), on #5 describe the problem, and #6 is not applicable to LASIK.
https://www.accessdata.fda.gov/scrip...tch-online.htm
Note that you can always leave fields blank and still move on from one screen to the next. However, you should be able to fill in most of the fields using the steps above. Please do this. It would be great to get more than 140 complaints in less than a month.
I'm eight years post-Lasik, still coping with night vision disturbances and dry eyes, and while I've done what I can talking to family and friends, worked with Rebecca on the website LaserMyEye, been a member here since this website started, and placed a front-page story on my local newspaper about my situation, I had never, ever, made such a report to the FDA.
I reproduce below YGB's message . . . because it is by now submerged in the thread about the FDA meeting on April 25th.
It took me about a half-hour to answer the questions, but only because I am chatty. Basically: what happened to you? what equipment was used? do you have objective evidence of your problem (dates, data/readouts/numbers)? what relevant history can you provide? (pre-existing conditions, etc.). You can skip items that don't apply, such as serial numbers of equipment, etc. At the very end you get to review your answers and have the opportunity to edit it all.
Thanks again to YGB, Lucy, Natalie06, and Rebecca for urging us to let our voices be heard!
mary (known to the "old-timers" as "gloomsburg" on SurgicalEyes)
===============================================
Here's what YGB posted:
No need for guilt. However, all LASIK sufferers should report their bad outcomes to the FDA. I posted this somewhere else, but here it is again ...
If we want the FDA to know "how serious and widespread the problem is", it is imperative that we report our bad outcomes to the FDA.
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. The web link below will take you to the "MedWatch Online Voluntary Reporting Form (3500)".
Then click on the BEGIN button to the right of the page. The Patient Identifier field can be left blank. On the next page, for #1 click on "Adverse Event", for #2 click "Disability or Permanent Damage" (assuming that is applicable to you), on #5 describe the problem, and #6 is not applicable to LASIK.
https://www.accessdata.fda.gov/scrip...tch-online.htm
Note that you can always leave fields blank and still move on from one screen to the next. However, you should be able to fill in most of the fields using the steps above. Please do this. It would be great to get more than 140 complaints in less than a month.
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