[pending] Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: T
Pending LLM rewrite. Source: FDA_DEVICE Z-2509-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
The recalled product
- Product
- Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric
- Manufacturer
- Staar Surgical AG
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 2026 to April 16
Distribution
Distributed nationwide across the United States.
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