BOSTON KERATOPROSTHESIS

Description of Event or Problem

BOSTON KERATOPROSTHESIS WAS ASSEMBLED BY THE CORNEA FELLOW IN TRAINING WHILE THE ATTENDING DOCTOR REMOVED THE PT'S CORNEA. WHILE ATTEMPTING TO USE THE LOCKING PIN TO LOCK THE TITANIUM RING OVER THE BACK PLATE, THE TOOL WAS IMPROPERLY POSITIONED OVER THE RING. WHEN DOWNWARD PRESSURE WAS APPLIED, THE TOOL WAS NOT PERFECTLY PERPENDICULAR AND CAUSED A FRACTURE OF THE BACK PLATE. SINCE THE HOST CORNEA WAS ALREADY REMOVED, THE DOCTOR DECIDED TO SUTURE THE GRAFT - PROSTHETIC COMBINATION WITHOUT BACK PLATE AS A TEMPORARY MEASURE. THE NEXT DAY, THE DOCTOR CONTACTED BOSTON KERATOPROSTHESIS AND FOLLOWING THE ADVICE OF BOSTON KPRO, HE SUCCESSFULLY COMPLETED THE SURGERY WITH A NEW BACK PLATE AND TITANIUM RING 2 DAYS LATER.

Additional Manufacturer Narrative

THE BROKEN BACK PLATE WAS CONFIRMED ON THE EXAMINATION OF THE RETURNED PRODUCT. THE INSTRUCTIONS FOR ASSEMBLY OF THE KPRO CALL FOR PUSHING THE LOCKING RING DOWN INTO THE GROOVE WITH THE ASSEMBLY PIN AT 90 DEGREES FROM THE FRONT PLATE. THE BREAKAGE CAN OCCUR IF THE TOOL IS NOT PERFECTLY PERPENDICULAR AND IT HITS THE BACK PLATE. THE INSTRUCTIONS CLEARLY INDICATE, THAT THE GRAFT-PROSTHETIC COMBINATION AFTER THE INSPECTION UNDER THE MICROSCOPE HAS TO BE REMOVED FROM THE ADHESIVE AND STORED IN THE EYE BANK SOLUTION WHILE THE PT'S EYE IS PREPARED. THE ASSEMBLY WAS PERFORMED BY AN INEXPERIENCED ASSISTANT, BUT THE PT'S CORNEA WAS ALREADY REMOVED AND THE DOCTOR DECIDED TO SUTURE THE GRAFT-PROSTHETIC COMBINATION INTO THE PT'S EYE AS A TEMPORARY MEASURE.