THE CONCERNED DEVICE "LACRIFAST" IS NOT DISTRIBUTED IN US UNDER THIS DEVICE NAME, BUT IS IDENTICAL TO THE DEVICE "LACRIFLOW LACRIMAL STENT" DISTRIBUTED IN US UNDER 510(K) # K120886; THE ACTUAL DEVICE USED WAS RETURNED AND INVESTIGATED:THE STAINLESS STEEL RING MOUNTED IN THE TIP OF THE COLORED IN BLUE TUBE WAS DISMOUNTED AND MISSING. ACCORDINGLY, THE MISSING STAINLESS STEEL RING MIGHT HAVE BEEN REMAINING IN THE PATIENT BODY. THE RING'S WHEREABOUTS WAS NOT CONFIRMED DURING THE PROCEDURE IN THIS EYE CLINIC; AS A POSSIBLE CAUSE OF THE PENETRATION OF THE BOUGIE AND DROPPING OFF THE RING DURING THE USE, WE SPECULATE AS FOLLOWS: WHEN THE DOCTOR TRIED TO INSERT AND ADVANCE THE TUBE WITH THE BOUGIE INSERTED FORCIBLY IN THE OCCLUDED LACRIMAL DUCT, EXCESSIVE MECHANICAL FORCE WAS LOADED ON THE RING AND THE DISTAL TIP OF THE TUBE WHERE THE RING WAS MOUNTED, AND FURTHER PUSHING THE BOUGIE RESULTED IN DISMOUNTING THE RING AND PENETRATION OF THE BOUGIE WITH THE RING OUT OF THE TUBE.
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Patient 1
THIS DEVICE (LACRIFAST) WAS EMPLOYED TO TREAT THE EPIPHORA DUE TO LACRIMAL DUCT OBSTRUCTION OF (B)(6) PATIENT. THE DOCTOR INSERTED ONE OF THE LACRIMAL DUCT TUBE (COLORED IN BLUE) INTO THE LACRIMAL DUCT BY DSI (DIRECT SILICONE INTUBATION) TECHNIQUE. WHILE ADVANCING THE TUBE, THE DOCTOR FELT THAT THE BOUGIE PENETRATED OUT OF THE TUBE AND RETRIEVED IT OUT OF THE PATIENT'S LACRIMAL DUCT. HE USED ANOTHER LACRIFAST AND COMPLETED THE OPERATION.