The Dry Eye Zone

Rebecca's Blog

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SmartPlug complications? REPORT THEM TO THE FDA!

Doctors:

If you have a patient who had canaliculitis or another complication from a SmartPlug, for goodness' sakes report it to the FDA on the MAUDE database.

Here's the link to MAUDE.

And while you're at it, make sure you report it to Medennium too on their Contact page. Device manufacturers are required to notify the FDA of post market complications they become aware of.

I just had a look and there are only 14 reports of SmartPlug complications on MAUDE - on this device that has been on the market almost a decade and which has been studied extensively. (To find them, search first under SmartPlug and separately under Smart Plug.)

14, seriously? How about the 19 in the Hill study, or the 41 in the study group, or the ones in the Chou study, Burgess study, Mazow study? Let alone the ones in all the other hundreds of cities (and not a few countries) where none of these study authors practice? Why isn't anybody reporting these things? How is the FDA supposed to monitor stuff if nobody ever tells them anything?

This is feeling like a rerun of Ladarvision, which left me absolutely heartsick. There were so many people affected and neither doctors nor the manufacturer were reporting the complications until the FDA practically sat on the manufacturer's head by recalling the device till the issues where addressed. Surely we can do better than this.

Patients:

If you have had a Smartplug complication of any kind, ask your doctor to report it to the FDA via MAUDE and to tell it to the manufacturer. If they are reluctant, do it yourself. Come to think of it, do it yourself anyway - if it's a duplication they'll figure it out and deal with it. See links above.

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I just learned that one of my oldest (in refractive surgery years that is) online eye pals was also a victim of this device and is facing surgery. Of all the people for this to happen to, did it have to happen to someone who already got the worst luck of the draw from RK? Really? 

Surely, surely we can stop more harm from happening. There is no need to let an evidently bad device sit on the market year after year while more people get harmed. 

Take action. Smart Plugs need to be withdrawn from the market. 
Rebecca1 Comment