LENSX LASER SYSTEM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. A MANUFACTURING DEVICE HISTORY RECORD REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. THE COMPANY REPRESENTATIVE WAS ABLE TO CONFIRM THE REPORTED ISSUE. THE TUNING MIRROR IN THE VIDEO MICROSCOPE WAS LOOSE. TO RESOLVE THE ISSUE, THE MIRROR WAS TIGHTENED AND THEN REALIGNED. THE SYSTEM WAS THEN TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO THE LOOSE TUNING MIRROR IN THE VIDEO MICROSCOPE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

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).

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 TWO RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT'S ONE UNKNOWN EYE AND ADDITIONAL MANUFACTURER REPORTS WILL BE FILED FOR THE OTHER PATIENT.