25 GA CURVED LASER PROBE

Additional Manufacturer Narrative

THE ROOT CAUSE IS UNABLE TO BE DETERMINED SINCE THE PHYSICAL PRODUCT WAS NOT RETURNED AND LOT NUMBER IS UNKNOWN. WITHOUT THE LOT NUMBER NEITHER DHR OR TRAINING DOCUMENTATION REVIEW CAN BE CONDUCTED. WE WILL MONITOR THE TREND OF THE COMPLAINT AND TAKE APPROPRIATE MEASURE TO ELIMINATE THE NATURE OF THE OCCURENCE.

Description of Event or Problem

STELLARIS AND LASER DID NOT WORK TOGETHER, THERE WAS POWER LACKING AND SURGEON NEEDED TO PUT THE POWER TO MAX TO GET A DECENT LASER BEAM. AFTER THAT THE POWER CAME BACK AND THE RETINA GOT DAMAGED. THERE MUST BE SOMETHING WRONG WITH LASER/CONNECTION/POWER OUTPUT.