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

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    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code POE·August 7, 2023

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code MJP·March 8, 2022

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code MFK·December 31, 2024

    CAUTERY 8442000 ACCU-TEMP 10PK FINE TIP

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code HQP·January 31, 2013

    TECNIS SYNERGY IOL

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code POE·June 22, 2022

    SENSAR IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·September 23, 2021

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Recall
    Terminated ·Carl Zeiss Meditec, Inc.·Product code HJO·October 23, 2013

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Recall
    Terminated ·Carl Zeiss Meditec, Inc.·Product code HJO·October 23, 2013

    BIOPSY NEEDLE KIT, PASSIVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code HAW·June 25, 2015

    MEDISENSE OPTIUM

    FDA Adverse Event
    Injury ·Product code NBW·January 5, 2010

    IMPLANT POS3000M 6PK PILLAR PALATAL

    FDA Adverse Event
    Injury ·XOMED MFG JACKSONVILLE·Product code LRK·October 22, 2012

    TECNIS SIMPLICITY

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·February 15, 2024

    1723170-2015-00375

    FDA Adverse Event
    Malfunction ·March 27, 2015

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    Casus Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·23 Manufacturers·593 Devices

    CEpartner4U

    Authorized representative
    🇳🇱 Netherlands·160 Manufacturers·5787 Devices

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    MedEnvoy Global BV

    Authorized representative
    🇳🇱 Netherlands·143 Manufacturers·2306 Devices

    Advena Limited

    Authorized representative
    🇲🇹 Malta·467 Manufacturers·13717 Devices