|Trade Name||ALCON LADARVISION 4000 EXCIMER LASER SYSTEM-|
|Classification Name||excimer laser system|
|Generic Name||ophthalmic excimer laser system|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a software calibration "lock-out" feature wherby the laser system will be "locked-out" to prevent the initiation of surgery more than 60 minutes after the last system calibration, a "countdown clock" on the computer monitor which will provide the user with feedback on the remaining time before the system will lock-out, and a software bug fix to correct a certain "bug" from occurring under certain conditions if the ruler tool was used with the tracker engaged during surgery.