Exposing the LASIK Scam

One Surgeon at a Time
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 Post subject: MDRs - Alcon vs. VISX
PostPosted: Wed Apr 26, 2006 8:43 pm 

Joined: Fri Mar 31, 2006 11:34 pm
Posts: 4
The Ladarvision has 97 device reports on the FDA MAUDE database for the period 2004-2006. They are very interesting, particularly all the ones describing lasers shutting down or failing to fire during a procedure, and some unusually large overcorrections.

Compare that to 9 reports for the same period for the VISX.

Then consider that the VISX dominates this market and Alcon's share is maybe 15% at best.

What does this math tell you?

According to Alcon's earnings conference call the other day, they are waiting for the FDA's response following a re-inspection of their Orlando facility. They have been unable to get approval for any further upgrades (such as their Ladarvision 6000 system) during the year that the FDA has had them 'on hold'. If the FDA gives them the thumbs up, that will be the clearest indication yet that the government is unable or unwilling to play any useful role in ensuring the post-market safety of these devices.

 Post subject:
PostPosted: Thu Apr 27, 2006 1:29 am 

Joined: Sat Nov 26, 2005 1:23 pm
Posts: 2080
What about VISX's clinical trials? They got the FDA thumbs up, even with poor accountability, missing data and covering up the pupil size issue. At least some ALCON users are honest about pupil size.

My guess is, if every patient who was damaged or doctor who damaged someone with a VISX laser filed an MDR, it would overload and crash the FDA website.

Don't get me wrong. I'm not saying LADARVision is a good laser. I think all lasers are junk when used on a healthy virgin eye for refractive surgery. They all make vision worse and permanently damage every single eye.

Disclosure: I was a -4.25 myope with no astigmatism. All it took was one surgery with a VISX laser to permanently destroy my vision.

Broken Eyes

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

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