ALCON - ORLANDO TECHNOLOGY CENTER LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM
Catalog Number 8065490084
Device Problem Tracking
Event Date 01/26/2006
Event Type Malfunction
Event Description
The tracker stopped tracking a patient's eye at 88% during a customer lasik procedure. They were unable to complete the procedure within the same session, however, there was no patient impact/injury associated with this event.
Manufacturer Narrative
H. 3. , h6. Evaluation summary: the field service engineer was dispatched to the site to evaluate the device. He was able to duplicate the difficulty with the tracker not tracking. He replaced the galvo box, dsp card, analog box, and completed an alignment of the tracker. Then he completed a system verification. The replaced parts were received in manufacturing, but the evaluation has not been completed.
http://www.accessdata.fda.gov/scripts/c ... _ID=680423
