CONSTELLATION Surgical Procedure Pack

Description of Event or Problem

A physician reported that vitrectomy probe when connected to the device, showed low cutting speed and could not start the cutting operation, also it still failed to cut as the cutting speed was reduced to 3000 cuts per minute and could not aspirate properly even when it was changed to different probe with same lot during vitrectomy surgery. The surgery was successfully completed on same day by replacing it with new product. There was no patient impact.

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)