WaveLight FS200 Femtosecond Laser

Description of Event or Problem

A nurse reported that patient had experienced a thin flap in the left eye during refractive surgery.There were two medical reports associated with the same patient. This report pertained to the left eye.

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).