Staar Surgical AG FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL CalculaClass IIApr 20, 2026Due to a software coding issues for calculating the implant	Due to a software coding issues for calculating the implant orientation diagram printout for the implantation	Class IIDevices	Apr 20, 2026
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5Class IIJan 21, 2026Toric Implantable Collamer for correction/reduction of myopi	Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as	Class IIDevices	Jan 21, 2026