| Level: | Consumer |
|---|---|
| Class: | II |
| Reference: | RN-2007-0347 |
| Date agreed: | 28 May 2007 |
| Product: | COMPLETE MoisturePlus contact lens solution |
| ARTG number: | 93540 |
| Batch number: | All batches |
| Sponsor: | Advanced Medical Optics Australia Pty Ltd |
| Contact: | COMPLETE MoisturePLUS Recall Hotline 1800 038 314 |
| Reason: | The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the US Centres for Disease Control and Prevention (CDC). |
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.