Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20631 |
| Brand Name: | Topcon Pascal Synthesis and Pascal Synthesis TwinStar (only with EpM software enabled) |
| Model: | |
| Affected: | |
| Software version: | 1.0.0, 1.0.1, 2.0.0, 3.1.1, 3.2.0, 3.3.0, 3.3.1 and 3.3.2) and 1.0.0, 1.0.1, 2.0.0, 3.1.1, 3.2.0, 3.3.0, 3.3.1 and 3.3.2) |
| Recalling Organisation: | Optimed NZ Ltd Unit 1 3 Northside Drive Whenuapai Auckland 0814 |
| Contact Information: | |
| Manufacturer: | Topcon Medical Laser Systems Inc |
| Issue: | An anomaly has been discovered with titration, only when the EpM software feauture is turrned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titration mode. In either single or multiple spot titration patterns, the power output upon pressing the footswitch is the same as the EpM power. The EpM power is a percentage of the power selected in the EpM control. The user would expect the power output during titration to be equal to 100% of the selected power level and may increase the power level during the titration process. When the expected tissue response is not observed, the power level resulting from titration will produce an over-power treatment when the user subsequently treats with the titration turned off. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/10/2016 |
