VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT)

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).

Description of Event or Problem

A NON-HEALTHCARE PROFESSIONAL REPORTED VIA HEALTH AUTHORITY THAT A VISCOELASTIC MATERIAL CONTROL TUBING WHICH WAS USED TO INJECT SILICONE OIL, COULD NOT BE CONNECTED TO THE INTERFACE OF THE VITRECTOMY MACHINE DURING VITRECTOMY SURGERY. IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.