Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15562 |
| Brand Name: | Amo STAR Excimer Laser System |
| Model: | S4 IR |
| Affected: | 6038 |
| Software version: | |
| Recalling Organisation: | AMO Australia Pty Limited (NZ) c/- Exel New Zealand Limited 3 - 5 Westfield Place Mt Wellington Auckland |
| Contact Information: | 0800 266 700 |
| Manufacturer: | AMO Manufacturing USA, LLC |
| Issue: | There is the potential to result in loss of illumination due to an unexpected failure of a component under high use conditions of the oblique and ring illumination lamps. This issue can be traced to overheating of a specific component found in a limited amount of STAR systems, which can result in a burning smell coming from the laser system. It does not affect laser pulse delivery. The treatment can continue without illumination of the surgical field at the surgeon's discretion. Since all treatment steps (pulse by pulse) are stored in non-volatile memory, in the event of treatment interruption, when illumination is restored the surgeon can resume the treatment at the point where it was interrupted. |
| Recall action type: | Correction |
| Recall action: | Product to be modified |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/10/2013 |
