Official recall notice
FDA DeviceClass IINotable
FDA Recall: Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: T
- Recall date
- 2026-06-24
- Brand
- Staar Surgical AG
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
Recommended action
What to do
543
Product description
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.