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| 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.