Viscous Fluid Control Tubing Set (Silicone Oil Inj/Ext)

Description of Event or Problem

A physician reported that tubing was blocked preventing silicon oil injection 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).