FDA Class II Recall: Product Name: STAAR ICL Calculation Software Software Version:… by Staar Surgical AG

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 (additional items listed in FDA's full record) -- and the recall number Z-2509-2026. If it matches, stop using or distributing it and contact Staar Surgical AG or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Staar Surgical AG and the affected product is described in FDA's record as: 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 (additional items listed in FDA's full record). FDA's stated reason for the recall is: Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.. The recall is tracked under FDA recall number Z-2509-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Staar Surgical AG’s FDA history

Argus HQ has recorded 1 total FDA action tied to Staar Surgical AG: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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 (additional items listed.

Has Staar Surgical AG had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Staar Surgical AG so far. Argus ingests new FDA enforcement records daily.

What is the FDA recall number for this event?

FDA recall number Z-2509-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Related enforcement actions