FDA DeviceClass IINotable

FDA Recall: Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: T

Date: 2026-06-24
Brand: Staar Surgical AG
Category: Medical Device
FDA Class: Class II

Description

Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

Hazard

Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

Remedy

543

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