WAVELIGHT FS200 FEMTOSECOND LASER

Description of Event or Problem

A HEALTHCARE PROFESSIONAL REPORTED THAT THE VERTICAL GAS BREAKTHROUGH AND THE TREATMENT WAS CONVERTED TO PHOTOREFRACTIVE KERATOMETRY IN THE UNKNOWN EYE OF A PATIENT, DURING REFRACTIVE SURGERY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT MD, UNKNOWN EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

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).