Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36884 |
| Brand Name: | STAAR Surgical AG - EVO Visian ICL V4c (VICMO) standard |
| Model: | Visian EVO ICL V4c (VICMO) standard |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Staar Surgical AG |
| Brand Name: | STAAR Surgical AG - EVO Visian ICL V4c (VTICMO) toric |
| Model: | Visian EVO ICL V4c (VTICMO) toric |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Staar Surgical AG |
| Brand Name: | STAAR Surgical AG - EVO Visian + (VICM5) standard |
| Model: | Visian EVO+ (VICM5) standard |
| Affected: | |
| Software version: | |
| Recalling Organisation: | KARL STORZ Endoscopy New Zealand Limited 31 Morningside Drive Mt Albert AUCKLAND 1025 |
| Contact Information: | |
| Manufacturer: | Karl Storz SE & Co KG |
| Brand Name: | STAAR Surgical AG - EVO+ Visian ICL (VTICM5) toric |
| Model: | Visian EVO+ (VTICM5) toric |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Staar Surgical AG |
| Brand Name: | STAAR Surgical - VICH lens |
| Model: | Visian ICL (VICH) |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Device Technologies New Zealand 47 Arrenway Drive Albany AUCKLAND 0632 |
| Contact Information: | 09 913 2000 |
| Manufacturer: | Staar Surgical AG |
| Brand Name: | STAAR Surgical - VTICH lens |
| Model: | Visian Toric ICL (VTICH) |
| Affected: | |
| 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 of problems that may affect information displayed on the Implant Orientation Diagram (IOD) that is generated in Stella 2.0. The IOD is used for the implantation of Toric EVO/EVO+ Implantable Collamer Lenses (ICLs). The identified problems are as follows: 1. Expected refraction, spherical equivalent, and/or model/version values may be incorrect on the generated IOD. 2. If the sphere value for a Toric lens reservation is null, Stella 2.0 will default to indicate a rotation value of 90° on the IOD. 3. Users' local office network firewall settings may block Stella 2.0 web browser functionality, impacting the IOD display. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/6/2026 |
