Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23535 |
| Brand Name: | CYPASS |
| Model: | |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Alcon Laboratories Australia Pty Ltd (NZ) c/- Pharmaco (NZ) Ltd 4 Fisher Crescent Mt Wellington Auckland |
| Contact Information: | 09 270 4360 |
| Manufacturer: | Transcend Medical Inc |
| Issue: | This Medical Device Recall is not related to a manufacturing or quality issue. Rather, this action has been initiated based on an analysis of the completed dataset from the COMPASS-XT long-term safety study. The analysis showed that the CyPass® Micro-Stent group experienced statistically significant endothelial cell loss (ECL) compared to the group who underwent cataract surgery alone. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 4/9/2018 |
