WAVELIGHT FS200 FEMTOSECOND LASER

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT THE SURGEON ENCOUNTERED A VERTICAL GAS BREAKTHROUGH AT THE HINGE RESULTED IN INCOMPLETE CUT IN THE RIGHT EYE OF THE PATIENT DURING REFRACTIVE SURGERY. THE SURGEON IMMEDIATELY STOPPED THE PROCEDURE AND RESTARTED USING A NEW PATIENT INTERFACE, PERFORMED A FULL FLAP CUT WITH THE SAME PARAMETERS. THE FLAP WAS SUCCESSFULLY LIFTED, AND THE EXCIMER TREATMENT WAS COMPLETED. NO PATIENT IMPACT HAS BEEN REPORTED AT THIS STAGE. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME.

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).