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 DURING CREATION OF FLAP A SURGEON WAS OBSERVED A THIN FLAP (THE FLAP WAS THINNER THAN INTENDED) AND THE FLAP WAS TORE IN THE UNKNOWN EYE OF A PATIENT DURING REFRACTIVE SURGERY. THE SURGERY WAS COMPLETED AFTER CHANGING TO A NEW PRODUCT. CURRENT PATIENT CONDITION IS UNKNOWN.