BEUDAMED
    736 results · 52ms · Sources: EU EUDAMED, US FDA

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    STAAR Surgical AG

    Manufacturer
    🇨🇭 Switzerland·1 Importer

    STAAR SURGICAL AG

    FDA registration
    STAAR SURGICAL AG·3 products·🇨🇭 Switzerland

    STAAR

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL AG·Product code HQL·December 24, 2003

    STAAR IOL

    FDA Adverse Event
    Injury ·STAAR SURGICAL AG·Product code HQL·June 1, 2004

    IMPLANTABLE COLLAMER LENS (NON-TORIC)

    FDA Adverse Event
    Injury ·STAAR SURGICAL AG·Product code MTA·January 13, 2020

    IMPLANTABLE COLLAMER LENS

    FDA Adverse Event
    Injury ·STAAR SURGICAL AG·Product code QCB·October 12, 2022

    STAAR Surgical AG

    Authorized representative
    🇪🇸 Spain·1 Manufacturer

    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 ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical AG·June 24, 2026

    EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

    FDA Enforcement
    Class II ·Ongoing·Staar Surgical AG·March 11, 2026

    Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.

    FDA Recall
    Terminated ·Medicel Ag Luchton 1262 Wolfhalden Switzerland·Product code HQL·August 5, 2013

    EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

    FDA Recall
    Open, Classified ·Staar Surgical AG Haupt Strasse 104 Nidau Switzerland·Product code QCB·January 21, 2026

    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 ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

    FDA Recall
    Open, Classified ·Staar Surgical AG Haupt Strasse 104 Nidau Switzerland·Product code MTA·April 20, 2026

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY AG·Product code MTA·November 2, 2016

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY AG·Product code MTA·November 9, 2016

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY AG·Product code MTA·October 21, 2016

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY AG·Product code MTA·December 20, 2016

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY AG·Product code MTA·November 10, 2016

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY AG·Product code MTA·November 9, 2016

    IMPLANTABLE COLLAMER LENS (ICL)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY AG·Product code MTA·December 22, 2016

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY AG·Product code MTA·October 14, 2016