Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01093-1
Product Name/Description Star Excimer Laser System (used to surgically correct visual refractive error in corneal surgery)

Model Number: S4 IR

Serial Number: 9271

ARTG Number: 120575
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 25/10/2013
Responsible Entity AMO Australia Pty Ltd
Reason/Issue The manufacturer is aware of an issue that has the potential to result in loss of illumination due to unexpected failure of a component under high use conditions of the oblique and ring illumination lamps. This issue can be traced to overheating of a specific component found in a limited amount of STAR system, which can result in a burning smell coming from the laser system.
Recall Action Recall for Product Correction
Recall Action Instructions Abbott Medical Optics (AMO Australia) is advising users that the printed circuit board of the affected units will be replaced prior to 31 January 2014. AMO is advising users to contact the AMO service representative in the case a system has a loss of illumination.
Contact Information 1800 266 111 - Abbot Medical Optics Australia