ALPHACOR; ALPHACOR-A, ALPHACOR-P ARTIFICAL CORNEA

Description of Event or Problem

IN 2003, ARGUS BIOMEDICAL WAS ADVISED BY A SURGEON VIA EMAIL THAT HIS PATIENT (IMPLANTED WITH THE ARGUS ALPHACOR KERATOPROSTHESIS IN 2001) HAD DEVELOPED A "SEMI-CIRCULAR BREAK IN THE KPRO OPTIC FROM 4.00 TO 11.00 O'CLOCK". THE PATIENT PRESENTED WITH ITCHING AND WATERING OF THE INVOLVED EYE. THE SURGEON WAS ADVISED THAT THE BEST COURSE OF ACTION WAS TO REPLACE THE DEVICE, PREFERABLY REINFORCING THE ANTERIOR SURFACE WITH DONOR TISSUE. THE SURGEON EXPLANTED THE DAMAGED KERATOPROSTHESIS AND PERFORMED REPLACEMENT SURGERY. THE SURGERY WAS REPORTED AS BEING UNEVENTFUL AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED TO DATE. THE PATIENT HAS HAD AN EXCELLENT OUTCOME FOLLOWING THE REPLACEMENT SURGERY AND FOLLOW UP CARE WILL CONTINUE TO BE PROVIDED.