WAVELIGHT FS200 FEMTOSECOND LASER

Description of Event or Problem

A PHYSICIAN REPORTED THAT DURING FLAP CREATION A THIN FLAP WAS OBSERVED, WHEN THE SURGEON LIFTED THAT FLAP A FLAP TEAR WAS OBSERVED IN THE PATIENT'S LEFT EYE DURING THE REFRACTIVE SURGERY. ACCORDING TO THE PHYSICIAN, THERE WERE NO APPARENT CORNEAL ABNORMALITIES PRIOR TO SURGERY, AND THE PROCEDURE WAS PERFORMED SMOOTHLY WITHOUT ANY SIGNIFICANT INTRAOPERATIVE ABNORMALITIES. THE FOLLOWING DAY, A SERVICE ENGINEER REPLACED THE PATIENT INTERFACE AND OTHER ASSOCIATED ACCESSORIES OF THE DEVICE. SUBSEQUENT PROCEDURES PERFORMED USING THE DEVICE AFTER REPLACEMENT WERE REPORTED TO BE NORMAL. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT INITIAL'S YX IN THE LEFT 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).