Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19003 |
| Brand Name: | Alcon Valved Entry System 3CT, 23Ga and 25Ga |
| Model: | 8065 751 657 (23Ga), 8065 751 658 (25Ga) |
| Affected: | Selected 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: | Alcon Laboratories Inc |
| Brand Name: | Alcon Total Plus 25+, 5.0 CPM Valve Wide |
| Model: | 8065 751 902 |
| Affected: | Selected 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: | Alcon Laboratories Inc |
| Brand Name: | Alcon Constellation Custom Paks |
| Model: | Selected packs |
| Affected: | Selected 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: | Alcon Surgical Inc |
| Issue: | The manufacturer advises that specific lots of its single-use 23 Gauge and 25 Gauge Valved entry systems have the potential to leak beyond their design specification. Leakage of fluid during ophthalmic surgery can lead to fluctuations of intraocular pressure (IOP) in patients. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Healthcare Professional |
| Date Commenced: | 27/8/2015 |
