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)
Top companies in HQL
| Company | 510(k)s | Recalls |
|---|---|---|
| AMO Puerto Rico Manufacturing, Inc. | 0 | 19 |
| Abbott Medical Optics Inc (AMO) | 0 | 14 |
| Bausch & Lomb Surgical, Inc. | 0 | 8 |
| Advanced Medical Optics, Inc. | 0 | 7 |
| Staar Surgical Co. | 1 | 5 |
| Aaren Scientific, Incorporated | 0 | 5 |
| Alcon Research LLC | 0 | 4 |
| Tekia Inc | 0 | 3 |
| Bausch & Lomb Inc | 0 | 2 |
| Hoya Surgical Optics, Inc. | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2026 | AMO 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 |
HQL | None listed |
| Aug 26, 2025 | Bausch & Lomb Surgical, Inc. Akreos, SKU: AO60P0300. Akreos intraocular lenses Open, Classified |
HQL | None listed |
| May 2, 2025 | Bausch & 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 |
HQL | None listed |
| Aug 3, 2023 | Johnson & Johnson Surgical Vision, Inc. TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only Open, Classified |
HQL | None listed |
| May 13, 2022 | Rayner 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 |
HQL | None listed |
| May 11, 2022 | Alcon Laboratories Ireland, Ltd Alcon Clareon IOL with AutonoMe Delivery System Terminated |
HQL | None listed |
| Jun 9, 2020 | Bausch & 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 |
HQL | None listed |
| Apr 17, 2020 | Alcon 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 |
HQL | None listed |
| Nov 14, 2018 | Johnson & 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 |
HQL | None listed |
| Nov 9, 2018 | Tekia, 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 |
HQL | None listed |
| Nov 5, 2018 | Bausch & 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 |
HQL | None listed |
| Aug 9, 2018 | Rayner 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 |
HQL | None listed |
| Sep 21, 2016 | Abbott 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 |
HQL | None listed |
| Sep 21, 2016 | Abbott 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 |
HQL | None listed |
| Sep 21, 2016 | Abbott 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 |
HQL | None listed |
| Sep 21, 2016 | Abbott 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 |
HQL | None listed |
| Sep 21, 2016 | Abbott 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 |
HQL | None listed |
| Sep 21, 2016 | Abbott 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 |
HQL | None listed |
| Sep 21, 2016 | Abbott 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 |
HQL | None listed |
| Sep 21, 2016 | Abbott 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 |
HQL | None listed |
| Sep 21, 2016 | Abbott 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 |
HQL | None listed |
| Sep 21, 2016 | Abbott 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 |
HQL | None listed |
| Sep 1, 2016 | Alcon 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 |
HQL | None listed |
| Nov 25, 2015 | Alcon 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 |
HQL | None listed |
| Nov 6, 2015 | Tekia, Inc. TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811 Terminated |
HQL | None listed |
| Aug 7, 2015 | Alcon 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 |
HQL | None listed |
| Jul 20, 2015 | Bausch & 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 |
HQL | None listed |
| Jul 20, 2015 | Bausch & Lomb Surgical, Inc. Bausch & Lomb SofPort Advanced Optics Aspheric Lens Terminated |
HQL | None listed |
| Mar 20, 2015 | Aaren 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Aug 26, 2014 | AMO 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 |
HQL | None listed |
| Mar 3, 2014 | AMO 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 |
HQL | None listed |
| Feb 20, 2014 | Bausch & 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 |
HQL | None listed |
| Aug 20, 2013 | Medicel 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 |
HQL | K070669 |
| Jul 17, 2013 | Staar 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 |
HQL | None listed |
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