Staar Surgical Company Stella 2.0 Implant Orientation Diagram (iod)
- Recalling firm
- Device Technologies New Zealand
- Product
- STAAR Surgical Company Stella 2.0 Implant Orientation Diagram (IOD). [Device]. Model: MYOPIC TORIC EVO VTICMO12.6-10.5. Affected: Serial number - T2717072
- Reason
- 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...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-08-17
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/afeaf3fe-885f-4563-8bf6-0433372f07ca