STAAR ICL calculation software miscalculates toric lens orientation diagram printout
STAAR ICL Calculation Software version 8.00 is being recalled because of a coding issue in calculating the implantation orientation diagram printout for toric implantable collamer lenses.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall where the printed orientation guidance for an implanted lens may be miscalculated, a risk of harm with no injuries reported.
Plain-English summary
The STAAR ICL Calculation Software, version 8.00, UDI (01)00840311346288(0812)8.00, from Staar Surgical AG, is being recalled. The software aids in calculating the size and diopter power for physician selection of the lens, and for toric ICLs it produces an Implantation Orientation Diagram. The action covers 543 units.
The stated reason is a software coding issue for calculating the implant orientation diagram printout for the implantation of toric implantable collamer lenses. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States across a large number of states and territories.
Users should identify affected installations using the software version and UDI above and follow the instructions issued by Staar Surgical.
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
- Affected units
- 543
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
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