Folders And Injectors, Intraocular Lens (iol)
Ophthalmic · 21 CFR 886.4300
Recent MDR events
5,350 adverse event reports on file
- EyeGility InserterJul 30, 2026InjuryBausch + Lomb0001313525-2026-00112
- CLAREON MONARCH IV IOL Delivery System, InjectorJul 28, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00789
- CLAREON MONARCH IV IOL Delivery System, InjectorJul 28, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00790
- lioli IOL Delivery SystemJul 27, 2026InjuryAst Products, Inc.1000635309-2026-00003
- EnVista SimplifEYE InjectorJul 27, 2026InjuryBausch + Lomb Inc.0001313525-2026-00105
- EnVista SimplifEYE InjectorJul 27, 2026InjuryBausch + Lomb Inc.0001313525-2026-00106
- Easy-Load Lens Delivery SystemJul 27, 2026InjuryBausch + Lomb Inc.0001313525-2026-00108
- MONARCH IOL DELIVERY SYSTEM, CARTRIDGEJul 22, 2026MalfunctionAlcon Research, Llc - Huntington1119421-2026-01547
- MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE DJul 22, 2026MalfunctionAlcon Research, Llc - Huntington1119421-2026-01557
- MONARCH IOL DELIVERY SYSTEM, CARTRIDGEJul 21, 2026MalfunctionAlcon Research, Llc - Huntington1119421-2026-01526
Event type breakdown
Recalls
5 recall events for this product code
- Alcon Research, Ltd.TerminatedJan 9, 2017
Alcon Monarch III (1) "C" Cartridge
The intraocular lens could become lodged within the cartridge
Z-0978-2017 · View FDA record ↗ - Beckman Coulter IncTerminatedJul 23, 2004
Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.
Z-1156-04 · View FDA record ↗ - Aaren Scientific Inc.TerminatedUnknown
AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren Scientific Inc., Ontar
The recommended storage temperature on the label is incorrect.
Z-0071-2018 · View FDA record ↗ - Rayner Intraocular Lenses LimitedOpen, ClassifiedUnknown
RaySert PLUS RSP01. LOT K030. Expiry of 2024-01 - Product Usage: The single use injectors (Model STWOl and Model RSPOl) are intended to be used to compress and
RaySert PLUS RSP01 LOT K030 labeled with an expiry of 2024-01 contained an inner tray that was labeled with an expiry of 2015. In addition to having an expiry of 2015 the LOT number on the inner tray is identified as V001.
Z-1753-2020 · View FDA record ↗ - Bausch & Lomb Surgical, Inc.TerminatedUnknown
SoftPort Easy-Load Lens Delivery System Model: EZ-28V
Complaints concerning kinked haptics that were occurring during lens delivery.
Z-2098-2017 · View FDA record ↗
Registered firms
119 firms currently registered for this product code
Ast Products, Inc.
Billerica, MA, US
Bausch & Lomb Incorporated
CLEARWATER, FL, US
Hoya Surgical Optics, Inc.
Irvine, CA, US
Bausch & Lomb Incorporated
Rochester, NY, US
Johnson & Johnson Surgical Vision, Inc.
Irvine, CA, US
Icares Medicus, Inc.
Zhubei Hsinchu, TW
Staar Surgical Company
Tustin, CA, US
Jellisee Ophthalmics Inc.
McLean, VA, US
Aurolab
MADURAI Tamil Nadu, IN
Alcon Research, Llc
Fort Worth, TX, US
Hoya Surgical Research Center
Tokyo, JP
Isomedix Operations, Inc.
Temecula, CA, US
Taiwan Advanced Sterilization Technology Inc.
Taichung County, TW
Lenstec Barbados, Inc.
CHRIST CHURCH, BB
U.s. Iol, Inc.
LEXINGTON, KY, US
510(k) clearances
63 clearances for this product code
- Rxsight, Inc.Jun 10, 2026
K261174 · RxSight® Insertion Device
- Medicel AGSep 16, 2025
K252540 · ACCUJECT Injector Set 2.1-1P (LP604590)
- Bausch & Lomb, IncorporatedOct 10, 2024
K242389 · EyeGility Inserter for Preloaded enVista IOLs
- Medicel AGSep 19, 2023
K231106 · Accuject Refra Injector AR2900
- Rxsight, Inc.Aug 15, 2023
K231838 · RxSight® Insertion Device (63002)
- Rxsight, Inc.Jun 12, 2023
K231466 · RxSight Insertion Device
- Alcon Laboratories, Inc.Aug 23, 2021
K212039 · CLAREON MONARCH IV IOL Delivery System
- Ast Products, Inc.Jun 4, 2020
K200057 · bioli lOL Delivery System