ReNu with Moistureloc
Medical device recall
| Level: | Consumer | Class: | II |
|---|---|---|---|
| Reference: | RN-2006-0389 | Date: | 19 May 2006 |
| Product: | ReNu with Moistureloc | ||
| ARTG number: | 116694 | ||
| Batch number: | All batches | ||
| Sponsor: | Bausch & Lomb (Australia) Pty Ltd | ||
| Phone: | 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.