ALPHACOR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-25 for ALPHACOR * manufactured by Argus Biomedical Pty Ltd..

Event Text Entries

[360788] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1032447
• MDR Report Key: 535463
• Date Received: 2004-06-25
• Date of Report: 2004-06-24
• Date of Event: 2004-06-12
• Date Added to Maude: 2004-07-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ALPHACOR
• Generic Name: CORNEAL PROSTHESIS
• Product Code: HQM
• Date Received: 2004-06-25
• Model Number: P
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 524706
• Manufacturer: ARGUS BIOMEDICAL PTY LTD.
• Manufacturer Address: 2 VERDUN STREET NEDLANDS, WEST AS

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-06-25