QUATERA 700, BIMANUAL I/A HANDPIECE SET

Additional Manufacturer Narrative

FINAL ROOT CAUSE ANALYSIS WILL BE PERFORMED BY THE MANUFACTURER ONCE THE PARTS ARE RETURNED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT BLUE, POSSIBLY PLASTIC BITS WERE NOTED AT THE I/A HANDPIECE TIP UNDER THE MICROSCOPE WHILST IN THE EYE. WHILE REMOVING THE VISCOELASTIC, TWO BLUE PIECES WERE NOTED IN THE IRRIGATION HOLE. ISSUE OCCURRED DURING OPHTHALMIC SURGERY. THE DOCTOR REMOVED THE I/A HANDPIECE AND THE BLUE BITS. THERE WAS NO INJURY TO ANYONE PRESENT AT THE TIME OF THE INCIDENT. NO AFTER-TREATMENT WAS NECESSARY. THERE WAS NO INFORMATION ABOUT ANY DELAY OF THE PROCEDURE.