CONSTELLATION Surgical Procedure Pack

Description of Event or Problem

A nurse reported that probe did not produce cuts at an unknown timing for vitrectomy surgery. The surgery completion details and patient impact details were unknown.Additional information has been requested. Response awaited.

Additional Manufacturer Narrative

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).