ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM
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
