WAVELIGHT FS200 FEMTOSECOND LASER

Description of Event or Problem

A PHYSICIAN REPORTED THAT A PARTIALLY UNCUT SIDE INCISION WAS OBSERVED BETWEEN THE ONE O'CLOCK AND FOUR O'CLOCK POSITIONS, RESULTING IN AN INCOMPLETE CUT IN THE PATIENT'S RIGHT EYE TO COMPLETE THE INCISION, THE SURGEON USED VANNAS SCISSORS TO CUT THE REMAINING UNCUT PORTION OF THE SIDE INCISION DURING REFRACTIVE SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY ON THE SAME DAY.

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).