ReNu with Moistureloc

Medical device recall

Increasing evidence suggesting an association between the product formulation and a rare eye infection (Fusarium keratitis).

Published

19 May 2006

Level:	Consumer
Class:	II
Reference:	RN-2006-0389
Date agreed:	19 May 2006
Product:	ReNu with Moistureloc
ARTG number:	116694
Batch number:	All batches
Sponsor:	Bausch & Lomb (Australia) Pty Ltd
Contact:	1800 251 150 Customer Service
Reason:	Increasing evidence suggesting an association between the product formulation and a rare eye infection (Fusarium keratitis).

Letters were dispatched on 17 May 2006

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I & II recalls are considered to be safety related recalls.

Product types