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Lens Plus OcuPure Saline Sterile Rinsing Solution 360mL

Medical device recall

Specific lots are being recalled because of production-line problems at AMO's manufacturing plant, which could affect the sterility of the product.

Published
Level:Consumer
Class:II
Reference:RN-2006-0803
Date agreed:23 November 2006
Product:Lens Plus OcuPure Saline Sterile Rinsing Solution 360mL
ARTG number:93540
Batch number:ZB02767
ZB03156
ZB03191
ZB03371
Sponsor:Advanced Medical Optics (AMO) Australia Pty Ltd
Contact:AMO customer service hotline 1800 266 111
Reason:Specific lots are being recalled because of production-line problems at AMO's manufacturing plant, which could affect the sterility of the product.

Letters are expected to be dispatched by the sponsor within two working days of the agreed date. Recall notices will be appearing in national newspapers from Monday 27 November 2006.

Please note other AMO products that are included in overseas recalls (eg COMPLETE MoisturePLUS Multipurpose Solution) are NOT affected by this recall in Australia.

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