SUPERBLADE TREPHINE

Description of Event or Problem

ACTUAL SIZE IMPRINTED ON TREPHINE WAS 7.5 MM, SIZE SHOWN ON CONTAINER WAS 8.5 MM. THIS WASN'T DISCOVERED UNTIL PHYSICIAN HAD CUT DONOR CORNEA AND THEN REALIZED THAT THE CORNEA IMPLANT WOULDN'T FIT. IMPLANT HAD TO BE REMOVED AND PT'S OWN CORNEA REINSERTED. UNDER A SEPARATE PROCEDURE, A SECOND DONOR CORNEA HAD TO BE CUT TO FIT THE 7.5 MM INCISION AND WAS IMPLANTED. PACKAGING OF TREPHINE IS IN TWO PARTS. OUTSIDE BOX DISPLAYS PRODUCT SIZE, INSIDE BUBBLE PACK DOESN'T DISPLAY SIZE. OUTSIDE BOX ISN'T SECURE IN ANY WAY TO PREVENT IT FROM BEING OPENED PRIOR TO USE.