WAVELIGHT FS200 FEMTOSECOND LASER

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 PHYSICIAN REPORTED THAT DOCTOR NOTICED NO SIDE CUT IN THE LEFT EYE OF THE PATIENT DURING REFRACTIVE SURGERY AND DECIDED TO ALLOW THE EYE TO HEAL FOR RETREATMENT AGAIN IN FEW WEEKS. THE PROCEDURE WAS NOT COMPLETED. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S LEFT EYE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.