ClearanceBrief
Panels › Ophthalmic › Product code HQL · Class 3

Intraocular Lens

Regulation 886.3600

0510(k)s in 12 months (5 all time)
1recalls in 12 months (75 all time)
1recalls that name a 510(k)
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Top companies in HQL

DateFirm and productCodeLinked 510(k)
Mar 24, 2026AMO Puerto Rico Manufacturing, Inc.
Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Produc
Open, Classified
HQLNone listed
Aug 26, 2025Bausch & Lomb Surgical, Inc.
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Open, Classified
HQLNone listed
May 2, 2025Bausch & Lomb Surgical, Inc.
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 I
Open, Classified
HQLNone listed
Aug 3, 2023Johnson & Johnson Surgical Vision, Inc.
TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Open, Classified
HQLNone listed
May 13, 2022Rayner Intraocular Lenses Ltd
RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph:
Open, Classified
HQLNone listed
May 11, 2022Alcon Laboratories Ireland, Ltd
Alcon Clareon IOL with AutonoMe Delivery System
Terminated
HQLNone listed
Jun 9, 2020Bausch & Lomb Surgical, Inc.
enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correct
Terminated
HQLNone listed
Apr 17, 2020Alcon Research LLC
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 O
Terminated
HQLNone listed
Nov 14, 2018Johnson & Johnson Surgical Vision Inc
Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia
Terminated
HQLNone listed
Nov 9, 2018Tekia, Inc.
TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.
Terminated
HQLNone listed
Nov 5, 2018Bausch & Lomb Surgical, Inc.
enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. T
Terminated
HQLNone listed
Aug 9, 2018Rayner Intraocular Lenses Limited
C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phaco
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
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 ha
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
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 presbyopi
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
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
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
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 cataractou
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
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 catara
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
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 re
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
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 catara
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
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
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopi
Terminated
HQLNone listed
Sep 21, 2016Abbott Medical Optics Inc. (AMO)
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 b
Terminated
HQLNone listed
Sep 1, 2016Alcon Research, Ltd.
Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the hum
Terminated
HQLNone listed
Nov 25, 2015Alcon Research, Ltd.
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
Terminated
HQLNone listed
Nov 6, 2015Tekia, Inc.
TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
Terminated
HQLNone listed
Aug 7, 2015Alcon Research, Ltd.
ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to re
Terminated
HQLNone listed
Jul 20, 2015Bausch & Lomb Surgical, Inc.
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia seco
Terminated
HQLNone listed
Jul 20, 2015Bausch & Lomb Surgical, Inc.
Bausch & Lomb SofPort Advanced Optics Aspheric Lens
Terminated
HQLNone listed
Mar 20, 2015Aaren Scientific, Incorporated
Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of the
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Aug 26, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the followin
Terminated
HQLNone listed
Mar 3, 2014AMO Puerto Rico Manufacturing, Inc.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.
Terminated
HQLNone listed
Feb 20, 2014Bausch & Lomb Surgical, Inc.
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a catarac
Terminated
HQLNone listed
Aug 20, 2013Medicel Ag
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.
Terminated
HQLK070669
Jul 17, 2013Staar Surgical Co.
Afinity CQ2015A Intraocular Lens The visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction.
Terminated
HQLNone listed

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