Panels › Ophthalmic › Product code MSS · Class 1
Folders And Injectors, Intraocular Lens (Iol)
Regulation 886.4300
1510(k)s in 12 months (63 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in MSS
| Company | 510(k)s | Recalls |
|---|---|---|
| Bausch & Lomb | 11 | 0 |
| Lenstec, Inc. | 5 | 0 |
| Medicel AG | 5 | 0 |
| Rayner Intraocular Lenses , Ltd. | 4 | 1 |
| Rxsight, Inc. | 5 | 0 |
| STAAR Surgical Company | 5 | 0 |
| Ast Products, Inc. | 4 | 0 |
| Alcon Research, Ltd. | 2 | 1 |
| Duckworth & Kent, Ltd. | 3 | 0 |
| Rayner Surgical, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 2026 | K261174 | RxSight® Insertion Device Rxsight, Inc. | MSS |
| Sep 16, 2025 | K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) Medicel AG, CH | MSS |
| Oct 10, 2024 | K242389 | EyeGility Inserter for Preloaded enVista IOLs Bausch & Lomb, Incorporated | MSS |
| Sep 19, 2023 | K231106 | Accuject Refra Injector AR2900 Medicel AG, CH | MSS |
| Aug 15, 2023 | K231838 | RxSight® Insertion Device (63002) Rxsight, Inc. | MSS |
| Jun 12, 2023 | K231466 | RxSight Insertion Device Rxsight, Inc. | MSS |
| Aug 23, 2021 | K212039 | CLAREON MONARCH IV IOL Delivery System Alcon Laboratories, Inc. | MSS |
| Jun 4, 2020 | K200057 | bioli lOL Delivery System Ast Products, Inc. | MSS |
| Jan 17, 2020 | K192926 | RxSight Insertion Device Rxsight, Inc. | MSS |
| Oct 4, 2019 | K192005 | Bausch + Lomb PreVue Inserter for enVista Preloaded Bausch & Lomb, Inc. | MSS |
| Sep 13, 2019 | K191949 | UNFOLDER Vitan Inserter Johnson & Johnson Surgical Vision, Inc. | MSS |
| Mar 29, 2019 | K182965 | BL-Cart IOL Delivery Cartridge Ast Products, Inc. | MSS |
| Jul 26, 2018 | K181401 | RxSight Insertion Device Rxsight, Inc. | MSS |
| Dec 15, 2017 | K172228 | pioli IOL Delivery System Ast Products, Inc. | MSS |
| Dec 11, 2017 | K173480 | Crystalsert Lens Delivery System Bausch & Lomb, Inc. | MSS |
| Sep 6, 2017 | K172375 | MicroSTAAR Injector System Cartridges STAAR Surgical Company | MSS |
| Nov 29, 2016 | K161776 | Lenstec LC Injection system Lenstec, Inc. | MSS |
| Jul 6, 2016 | K161012 | Easy-Load Lens Delivery System Bausch and Lomb, Inc., | MSS |
| May 22, 2015 | K151102 | Bausch + Lomb Injector System Bausch & Lomb, Inc. | MSS |
| May 6, 2015 | K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series Abbott Medical Optics, Inc. | MSS |
| Apr 9, 2015 | K142056 | LIOLI IOL DELIVERY SYSTEM Ast Products, Inc. | MSS |
| Dec 18, 2014 | K143307 | RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector Rayner Intraocular Lenses , Ltd., GB | MSS |
| May 28, 2014 | K141091 | RAYSERT PLUS INJECTOR Rayner Intraocular Lenses , Ltd., GB | MSS |
| Mar 27, 2014 | K132002 | SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR Rayner Intraocular Lenses , Ltd., GB | MSS |
| Jan 9, 2014 | K131958 | BAUSCH & LOMB INJECTOR SYSTEM Bausch & Lomb | MSS |
| Jan 3, 2014 | K133146 | BAUSCH + LUMB, VIS100 INJECTOR SYSTEM Bausch & Lomb | MSS |
| Dec 27, 2013 | K132481 | EASY-LOAD LENS DELIVERY SYSTEM Bausch & Lomb | MSS |
| Oct 18, 2013 | K122848 | LENSTEC LC INJECTION SYSTEM Lenstec, Inc. | MSS |
| Sep 17, 2013 | K132593 | CRYSTALSERT DELIVERY SYSTEM Bausch & Lomb | MSS |
| May 16, 2013 | K123736 | CRYSTALSERT DELIVERY SYSTEM Bausch & Lomb | MSS |
| Apr 15, 2013 | K123888 | Z CARTRIDGE IOL DELIVERY SYSTEM Aaren Scientific, Inc. | MSS |
| Sep 28, 2012 | K113852 | BAUSCH & LOMB IOL INJECTOR Bausch & Lomb, Inc. | MSS |
| Mar 27, 2012 | K112977 | MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) Alcon Research, Ltd. | MSS |
| Oct 13, 2011 | K101774 | MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) Alcon Manufacturing, Ltd. | MSS |
| Jun 29, 2011 | K103495 | ASICO SOFTIP INJECTOR SYSTEM Asico, LLC | MSS |
| Dec 22, 2010 | K101782 | MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE Staar Japan | MSS |
| Aug 9, 2010 | K101134 | VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 Medicel AG | MSS |
| Dec 4, 2009 | K091507 | RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 Rayner Intraocular Lenses , Ltd., GB | MSS |
| Jul 28, 2009 | K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 Medicel AG | MSS |
| Jul 9, 2009 | K082871 | XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM Sis Ltd., Surgical Instrument Systems | MSS |
| Jun 9, 2009 | K090161 | EPIPHANY INJECTION SYSTEM Staar Surgical Co. | MSS |
| Mar 23, 2009 | K081346 | HOYA IS INJECTOR SYSTEM Hoya Surgical Optics, Inc. | MSS |
| Oct 16, 2008 | K082944 | CRYSTALSERT CRYSTALENS DELIVERY SYSTEM Bausch & Lomb, Inc. | MSS |
| Oct 2, 2008 | K081545 | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 Advanced Medical Optics, Inc. | MSS |
| Sep 5, 2008 | K081455 | RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06 Rayner Surgical, Inc., GB | MSS |
| Mar 13, 2008 | K073591 | MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM Staar Surgical Co. | MSS |
| Mar 13, 2008 | K073586 | MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM Staar Surgical Co. | MSS |
| Nov 7, 2007 | K073010 | ROYALE AE 9036 LSP INJECTOR Asico, LLC | MSS |
| May 7, 2007 | K063802 | LENSTEC LC INJECTION SYSTEM Lenstec, Inc. | MSS |
| Dec 13, 2006 | K062612 | RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04 Rayner Surgical, Inc., GB | MSS |
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