Exposing the LASIK Scam

One Surgeon at a Time
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 Post subject: LadarVision malfunction on 02/09/2006
PostPosted: Tue May 23, 2006 7:26 pm 

Joined: Sun Jan 08, 2006 7:04 am
Posts: 38

Catalog Number 8065490006
Device Problem Error message given
Event Date 02/09/2006
Event Type Malfunction
Event Description
While on-site for a service visit, the field service engineer observed the laser not firing during a surgical procedure and the procedure was not completed within the same session. It s not known wether there was pt impact/injury associated with this event.

Manufacturer Narrative
H. 3. , h. 6. : evaluation summary: the field service engineer was at the site on a service call when the event happened. He examined the system and found the thyratron to be faulty. He replaced the laser chassis assembly, replaced the gas bottle and completed a system verification. The returned part was tests and evaluated by manufacturing and a faulty thyratron within the chassis was verified.

http://www.accessdata.fda.gov/scripts/c ... _ID=686984

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