Exposing the LASIK Scam

One Surgeon at a Time
It is currently Sat Oct 20, 2018 7:44 pm

All times are UTC




Post new topic Reply to topic  [ 1 post ] 
Author Message
 Post subject: VISX, you withheld data from your wavefront LASIK PMA
PostPosted: Mon Dec 19, 2005 12:48 am 
Offline
 Profile

Joined: Mon Nov 14, 2005 4:28 pm
Posts: 643
Strangely VISX collected post-op contrast sensitivity data but
failed to report it in their PMA (for patients reading... this is the
data from clinical trials that is submitted for approval). Isn't it odd
that the FDA let this PMA slide through anyway?

Then there is the odd fact that VISX left out over 70% of their
clinical outcomes from the PMA.

>From the full text:

"...the refractive outcomes for >70% of the study population are not
reported."

http://www.ncbi.nlm.nih.gov/entrez/quer ... =pubmed&...

J Refract Surg. 2004 Sep-Oct;20(5):S588-92.

Understanding pre-market approval and labeling differences of two
leading customized ablation platforms: a call for reform at the FDA.

Wachler BS, Hiatt JA.
Boxer Wachler Vision Institute, Beverly Hills, CA 90210, USA.
b...@boxerwachler.com


Top
 
Display posts from previous:  Sort by  
Post new topic Reply to topic  [ 1 post ] 

All times are UTC


Who is online

Users browsing this forum: No registered users and 2 guests


You cannot post new topics in this forum
You cannot reply to topics in this forum
You cannot edit your posts in this forum
You cannot delete your posts in this forum
You cannot post attachments in this forum

Search for:
Jump to:  
cron
Powered by phpBB © 2000, 2002, 2005, 2007 phpBB Group  
Design By Poker Bandits