LENSX LASER SYSTEM

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE TREATMENTS WAS OFF BY TWO MILLIMETERS IN CUT PLACEMENT FROM THE ACTUAL CUT, STATING THAT THE CUTS WERE MORE SUPERIOR THAN THE SURGEON PLACED THEM WITH THE OVERLAYS IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT'S TWO UNKNOWN EYE AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED FOR THE OTHER PATIENT.

Additional Manufacturer Narrative

H.3., H.6.: INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).