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

Description of Event or Problem

A NON-HEALTH CARE PROFESSIONAL REPORTED VIA HEALTH AUTHORITY THAT DURING THE RIGHT EYE VITRECTOMY, RETINAL DETACHMENT REDUCTION, AND SILICONE OIL FILLING SURGERY, THE OPERATING SURGEON DID NOT SECURELY FIX THE SILICONE OIL AND THE SILICONE OIL RESERVOIR TO THE TUBING INTERFACE. AFTER THE INFUSION PRESSURE OF THE DEVICE WAS INITIATED, THE CONNECTION COMPONENT OF THE SILICONE OIL RESERVOIR WAS DISLODGED AND EJECTED. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

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).