2940 NM LASER SCITON, INC.

UPON INVESTIGATION BY SCITON STAFF, IT WAS DETERMINED THAT THE CLINICIAN TREATED THE PATIENT WITHOUT DISINFECTING THE PROFRACTIONAL-XC HANDPIECE. THE INSTRUCTIONS IN THE OPERATOR MANUAL REQUIRES THE HANDPIECE TO BE CLEANED AND DISINFECTED PRIOR TO REUSE. NO MALFUNCTION OF THIS DEVICE WAS REPORTED WITH THIS EVENT.

A CLINICIAN TREATING A PATIENT WITH NON-DISINFECTED PROFRACTIONAL-XC STANDOFF REPORTED THAT THE PATIENT DEVELOPED INFECTION AND REQUIRED HOSPITALIZATION.