Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37293 |
| Brand Name: | STAAR Surgical Company Stella 2.0 Implant Orientation Diagram (IOD) |
| Model: | MYOPIC TORIC EVO VTICMO12.6-10.5 |
| Affected: | Serial number - T2717072 |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Staar Surgical AG |
| Issue: | The manufacturer has become aware that a limited number of IODs generated have the risk of an IOD with an incorrect axis value that could be clinically significant. Specifically, per the review of data in Stella 2.0, the IOD generated for a device you had ordered has a different axis placement than what had been reserved in Stella 2.0. Investigation points to an issue arising from migration of data from Stella 1.0 to Stella 2.0 associated with Made to Order (MTO) Toric ICLs. This data migration occurred prior to release of Stella 2.0 on April 13, 2026. The following three failure modes could result in this error: 1. Different IODs could be generated for the same serial number and one of the IODs from the record migrated from Stella 1.0 to Stella 2.0 displays an incorrect axis value, resulting in an incorrect rotation diagram. 2. Stella 2.0 could incorrectly generate an IOD diagram with no lens rotation required. 3. A number of migrated records were converted with null axis values. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/8/2026 |
