ALPHACOR
Received Jun 25, 2004 · Event occurred Jun 12, 2004
Report MW1032447 · MDR key 535463
Device
Generic name
Corneal Prosthesis
Manufacturer
Argus Biomedical Pty Ltd.Model number
PCatalog number
*
Lot number
*
Product problems
- Displacement
- Explanted
Patient
77 YR
- Unspecified Infection
- Loss of Vision
- Discomfort
- Surgical procedure
- Treatment with medication(s)
Narrative
Description of Event or Problem
PT HAD RECEIVED A CORNEAL PROSTHESIS. PT COMPLAINED OF DISCOMFORT: EXAMINATION REVEALED PROSTHESIS DISPLACED, WITH SOME INFECTION. PROSTHESIS WAS REMOVED AND A TISSUE GRAFT WAS MADE. PRIOR TO EVENT (CAUSE UNK) PT HAD 20/200 VISION IN THE RIGHT EYE; SUBSEQUENT TO REMOVAL AND GRAFT, PT HAS NO VISION IN THAT EYE. PT WAS TAKEN TO SURGERY AND THE PROSTHESIS AND UNDERLYING CORNEA TREPHINED OUT EN BLOCK, REVEALING AN ENDOPHTHALMITIS WHICH WAS NOT ACUTE AND MUST HAVE BEEN PRESENT FOR SEVERAL DAYS. PUT IN ANTIBIOTICS AND PLACED A GRAFT, BUT OF COURSE THERE IS NO VISION. DR CAN ONLY SURMISE THAT PT RUBBED THE SURFACE, EXTRUDING THE PROSTHESIS THROUGH THE ANTERIOR OPENING, AND INFECTION ENSUED.