ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM
Catalog Number 8065490084
Device Problem Error message given
Event Date 02/03/2006
Event Type Malfunction
Event Description
A system operator reports an error message, "energy level too low", at approx 20% into a lasik procedure. They performed a gas change, which was unsuccessful, and were unable to complete the procedure within the same session. The pt's procedure was completed later the same day following the field service engineer's visit. There was no pt impact/injury associated with this event.
Manufacturer Narrative
Eval summary: the field service engineer (fse) found the gas fill count at 'zero' and the customer was not able to complete any more gas changes. The fse added 2 gas fills from the gas cylinder reserve located on the system and was able to perform system calibration and complete a system verification. The customer was then able to continue with surgery.
http://www.accessdata.fda.gov/scripts/c ... _ID=682670
