BOSTON KERATOPROSTHESIS

Additional Manufacturer Narrative

IT APPEARS THAT THE DURING SHIPMENT OR SUBSEQUENT HANDLING THE BACK PLATE SLIPPED ONTO THE STEM OF THE FRONT PLATE. THE CLOCKING RING WAS NOT ENGAGE, SO THE DEVICE WAS NOT TRULY ASSEMBLED. THE CHIP IN THE BACK PLATE AS CONFIRMED ON EXAMINATION. A REVIEW OF THE PACKAGING AND ASSEMBLY OR BOSTON KERATOPROSTHESIS WAS REVIEWED AND THE INSPECTIONS FOR THE COMPONENTS SHOWED NO INDICATION OF DAMAGE OR CHIPS. THE PACKAGING PROCESS REQUIRES TWO SEPARATE MICROSCOPIC EXAMINATIONS OF EACH COMPONENT OR DEBRIS OR DAMAGE.

Description of Event or Problem

UPON OPENING PACKAGE AND INSPECTING THE BOSTON KERATOPROSTHESIS, FRONT PLATE AND BACK PLATE WERE ASSEMBLED- WHEN INSPECTING FRONT PLATE, SMALL CHIP NOTED IN OPTIC WITH CHIP PIECE MISSING. NO PATIENT INVOLVEMENT.