Lens Plus OcuPure Saline Sterile Rinsing Solution 360mL
Medical device recall
| Level: | Consumer | Class: | II |
|---|---|---|---|
| Reference: | RN-2006-0803 | Date: | 23 November 2006 |
| Product: | Lens Plus OcuPure Saline Sterile Rinsing Solution 360mL | ||
| ARTG number: | 93540 | ||
| Lot numbers: |
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| Sponsor: | Advanced Medical Optics (AMO) Australia Pty Ltd | ||
| Phone: | 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.