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    TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614, intraocular lens (IOL)

    FDA Recall
    Terminated ·Tekia Inc·Product code HQL·July 2, 2004

    TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code POE·July 6, 2023

    TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code HQL·July 6, 2023

    IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.

    FDA Recall
    Terminated ·Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany·Product code HJO·October 27, 2015

    AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.

    FDA Recall
    Terminated ·Abbott Medical Optics Inc (AMO)·Product code HQL·December 20, 2012

    Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code HQL·September 29, 2015

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for 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.

    FDA Recall
    Terminated ·Carl Zeiss Meditec AG Carl Zeiss Promenade 10 Jena Germany·Product code HJO·October 27, 2015

    SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016

    TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016

    TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016

    SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016

    TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016

    TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016

    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016

    Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;

    FDA Recall
    Open, Classified ·Bausch & Lomb Surgical, Inc.·Product code HQL·March 27, 2025

    TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. The lens is intended to be placed in the capsular bag.

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016

    Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS.

    FDA Recall
    Terminated ·Alcon Research LLC Aspex Facility·Product code HQL·April 17, 2020

    Pentacam HR REF 70900. Used to image the anterior segment of the eye.

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·July 8, 2022

    Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.

    FDA Recall
    Open, Classified ·Oculus Optikgeraete GMBH Munchholzhauser Str. 29 Wetzlar Germany·Product code MXK·July 8, 2022

    TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction and who desire near, intermediate, and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag

    FDA Recall
    Terminated ·Abbott Medical Optics Inc. (AMO)·Product code HQL·August 26, 2016