Monarch 00380659777745Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Monarch IV IOL Delivery System for use with Clareon only · Class 1
All models of MONARCH (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Clareon Monarch IV delivery system is an injector used to insert Clareon intraocular lenses during cataract surgery. Of its 275 reports, 10 are injury reports and 265 are malfunction reports, with no deaths. Many describe the plunger failing to push the lens out, lenses getting stuck in the cartridge, and cracks at the injector. Reports fell from 58 in the previous year to 29 in the latest year. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 270
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 270 adverse event reports that list this exact device (DI 00380659777745), received between Mar 25, 2022 and Sep 18, 2026 — classified as 10 injuries, 260 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (182 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Damaged by Another Device182
- Material Twisted/Bent51
- Failure to Eject35
- Defective Device15
- Device Contamination with Chemical or Other Material9
- Inaccurate Delivery9
- Defective Component8
- Difficult to Advance7
Patient problems
- Insufficient Information153
- No Clinical Signs, Symptoms or Conditions112
- Capsular Bag Tear3
- Visual Impairment2
- Corneal Edema1
- Intraocular Pressure Increased1
- Visual Disturbances1
- Vitreous Floaters1
Recent adverse event reports
The 25 most recent of 270 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Product Quality Problem
A healthcare professional reported that, during an intraocular lens (IOL) implantation procedure, the internal plunger used to advance the implant was not properly aligned, resulting in an injector malfunction. At the surgeon's request, another injector was provided so that the IOL could be implanted, as the first injector could not be used for implantation. The operating room nurses were not in a position to determine the cause of the injector malfunction. The originally scheduled procedure was completed on same day with no patient impact.Additional information was requested but was not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818237 ↗MalfunctionSep 18, 2026Product Quality Problem; Material Twisted/Bent
A healthcare professional reported that, during an intraocular lens (IOL) implantation procedure, the internal plunger used to advance the implant was not properly aligned, resulting in an injector malfunction. At the surgeon's request, another injector was provided so that the IOL could be implanted, as the first injector could not be used for implantation. The operating room nurses were not in a position to determine the cause of the injector malfunction. The originally scheduled procedure was completed on same day with no patient impact.Additional information was requested but was not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818231 ↗MalfunctionJul 28, 2026Device Damaged by Another Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50051478 ↗MalfunctionJul 28, 2026Device Damaged by Another Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50050545 ↗MalfunctionJun 25, 2026Material Twisted/Bent
A NURSE REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT USED DUE TO AN INJECTOR OVERRIDE, UPON INSPECTION THEY NOTICED THAT THE IOL BECAME STUCK IN THE CARTRIDGE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER SWITCHING OUT THE IOL, CARTRIDGE, AND INJECTOR. THE IOL DID NOT ENTER THE EYE, AS THE ISSUE WAS NOTICED DURING LOADING. THE DOCTOR BELIEVES THE ISSUE WAS CAUSED BY A FAULTY INSERTER. ADDITIONAL INFORMATION HAD BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS PATIENT CONTACT, AND IT WAS DUE TO BAD INSERTER.
Patient problems: Insufficient Information
MAUDE report 25620282 ↗MalfunctionJun 25, 2026Material Twisted/Bent
A NURSE REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT USED DUE TO AN INJECTOR OVERRIDE, UPON INSPECTION THEY NOTICED THAT THE IOL BECAME STUCK IN THE CARTRIDGE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER SWITCHING OUT THE IOL, CARTRIDGE, AND INJECTOR. THE IOL DID NOT ENTER THE EYE, AS THE ISSUE WAS NOTICED DURING LOADING. THE DOCTOR BELIEVES THE ISSUE WAS CAUSED BY A FAULTY INSERTER. ADDITIONAL INFORMATION HAD BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS PATIENT CONTACT, AND IT WAS DUE TO BAD INSERTER.
Patient problems: Insufficient Information
MAUDE report 25620279 ↗MalfunctionJun 8, 2026Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING A CATARACT INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS FOUND TO BE DAMAGED BY THE COMPANY INJECTOR WHEN IT WAS IMPLANTED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 3.
Patient problems: Insufficient Information
MAUDE report 25428340 ↗MalfunctionJun 8, 2026Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING A CATARACT INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS FOUND TO BE DAMAGED BY THE COMPANY INJECTOR WHEN IT WAS IMPLANTED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.
Patient problems: Insufficient Information
MAUDE report 25428339 ↗MalfunctionJun 3, 2026Device Damaged by Another Device
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IT WAS OBSERVED THAT THE LENS WAS DAMAGE BY THE INJECTOR, AND THE CRACK WAS NOTICED AFTER THE LENS WAS IMPLANTED. THE CRACK WAS LOCATED WHERE THE INJECTOR TOUCHED THE LENS. THE LENS WAS SUBSEQUENTLY REMOVED DURING INITIAL PROCEDURE AND THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25374447 ↗MalfunctionJun 3, 2026Device Damaged by Another Device
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, CRACK WAS OBSERVED WHERE THE INJECTOR MEETS THE LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25374446 ↗MalfunctionJun 3, 2026Device Damaged by Another Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE AT THE TIME OF DELIVERY OF LENS, MULTIPLE PERIPHERAL SCRATCHES AND SEVERED TRAILING HAPTIC WAS NOTICED. THE IOL WAS SUBSEQUENTLY REMOVED AND REPLACED WITH COMPANY LENS DURING INITIAL IMPLANTATION PROCEDURE AND PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25372179 ↗MalfunctionMay 8, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING LOADING, THE INJECTOR ADVANCED OVER THE LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. ACCORDING TO THE NEW INFORMATION RECEIVED, WHILE THE SURGEON WAS ADVANCING THE INJECTOR, IT WAS ADVANCED OVER THE LENS. THE SURGEON THOUGHT IT MIGHT BE THE INJECTOR PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125086 ↗MalfunctionApr 22, 2026Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INSERTED INTO THE EYE WITH THE INJECTOR SET AS USUAL, AND THE IOL WAS CONFIRMED TO BE DAMAGED.
Patient problems: Insufficient Information
MAUDE report 24955523 ↗MalfunctionApr 2, 2026Inaccurate Delivery; Device Damaged by Another Device; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY IT WAS OBSERVED THAT ALL FOUR HANDPIECES FAILED TO ENGAGE PROPERLY WITH THE LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION RECEIVED THAT THE ISSUE WITH FIVE HANDPIECES.
Patient problems: Insufficient Information
MAUDE report 24769358 ↗MalfunctionMar 25, 2026Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT, THE INNER CYLINDER RODE OVER THE INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SURGEON DID NOT REPORT ANY IOL DAMAGE CAUSED BY THE FAILURE OF THE COMPANY¿S INJECTOR.
Patient problems: Insufficient Information
MAUDE report 24686788 ↗MalfunctionMar 2, 2026Material Twisted/Bent
A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN USING THE CARTRIDGE, THE SURGEON NOTICED A SERIES OF IMPLANTATION FAILURES. THE PISTON OF THE INJECTOR MISSED AND PASSED OVER LENS. NO ABNORMALITIES WERE OBSERVED WITH THE INJECTOR AND IMPLANT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE WHEN THE SPECIFIC MODEL OF COMPANY INJECTORS USED WITH SPECIFIC MODEL OF COMPANY CARTRIDGE THE PLUNGER SOMETIMES FAILS TO CATCH THE IMPLANT.
Patient problems: Insufficient Information
MAUDE report 24484890 ↗MalfunctionFeb 27, 2026Material Twisted/Bent
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471149 ↗MalfunctionFeb 26, 2026Device Damaged by Another Device
A NON¿HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS SCRATCHED BY THE INSERTER. PATIENT CONTACT OCCURRED AND PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24456076 ↗MalfunctionFeb 12, 2026Inaccurate Delivery; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION PROCEDURE 3 NURSES USED THE SAME INJECTOR, DIFFICULTY ADVANCING LENS DUE TO RESISTANCE WAS OBSERVED AND 2 NOTED DAMAGE TO LENSES ON ONE OCCASION EACH.
Patient problems: Insufficient Information
MAUDE report 24322230 ↗MalfunctionFeb 10, 2026Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) PROCEDURE, THE LENS WAS DAMAGED BY THE INJECTOR THAT BOTH HAPTICS DETACHED FROM LENS DURING INSERTION AND THE OPTIC STAYED IN CARTRIDGE WHEREAS BOTH HAPTICS WAS INJECTED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24310834 ↗MalfunctionFeb 6, 2026Device Damaged by Another Device; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN SURGEON WAS INSERTING THE LENS IN THE EYE, SURGEON VERBALIZED WHEN ROTATING FORWARD THE INJECTOR FOR THE IOL GO IN THE EYE, NOTICED THAT THE TIP OF THE INJECTOR WAS ABOVE THE LENS. THE INITIAL LENS HAD A SCRATCH LOCATED AT THE CENTER OF THE LENS AND SCRUB NURSE RELOADED A NEW LENS. THE SURGEON DECIDED TO CUT AND EXPLANT THE IOL AND INSERTED A NEW ONE AND USED COMPANY ANOTHER INJECTOR.
Patient problems: Insufficient Information
MAUDE report 24279562 ↗MalfunctionJan 6, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED A RISK OF LENS DAMAGE AS THE PLUNGER SLIPPED UNDER THE LENS INTO THE CARTRIDGE. THE SURGERY WAS COMPLETED WITH BACK UP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23977777 ↗MalfunctionDec 28, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR DAMAGED THE LENS. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT, THE LENS WAS IMPLANTED AND LATER EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23903605 ↗MalfunctionDec 26, 2025Device Damaged by Another Device; Material Twisted/Bent; Device Damaged by Another Device; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED BY THE COMPANY INJECTOR, POSSIBLY DUE TO A BENT OR DAMAGED INJECTOR. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT A SCRATCH HAD BEEN NOTICED DURING LOADING, AND THE LENS HAD BEEN PUT BACK IN THE WAGON WHEEL. THERE HAD BEEN NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23898208 ↗MalfunctionOct 31, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; AFTER IMPLANTING THE LENS, SURGEON LOOKS UNDER THE MICROSCOPE THAT THE LENS IS MARKED ON ITS PERIPHERY CAUSED BY THE INJECTOR. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438540 ↗
Other Folders and injectors, intraocular lens (iol) devices
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- BLIS-X1Bausch & Lomb Incorporated · Folders And Injectors, Intraocular Lens (Iol)23 reports
- Bausch + Lomb EZ-28Bausch & Lomb Incorporated · Folders And Injectors, Intraocular Lens (Iol)23 reports
- RxSight Insertion Device 63002Rxsight, Inc. · Folders And Injectors, Intraocular Lens (Iol)17 reports
- Sofport Easy-Load Lens Delivery System EZ-24Bausch & Lomb Incorporated · Folders And Injectors, Intraocular Lens (Iol)11 reports
- RxSight Injector Handpiece 63001Rxsight, Inc. · Folders And Injectors, Intraocular Lens (Iol)9 reports
- Bausch + Lomb BLIS-R1Bausch & Lomb Incorporated · Folders And Injectors, Intraocular Lens (Iol)7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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