MONARCHRecalls & reported problems across all models
Alcon Laboratories, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 319
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 2 models of MONARCH by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 319 adverse event reports in the FDA's MAUDE database, received between Jun 1, 2021 and Sep 25, 2026 — classified as 18 injuries, 301 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (199 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MONARCH problems
Device problems
- Device Damaged by Another Device199
- Material Twisted/Bent51
- Failure to Eject37
- Defective Device18
- Defective Component11
- Device Contamination with Chemical or Other Material11
- Difficult to Advance9
- Inaccurate Delivery9
Patient problems
- Insufficient Information171
- No Clinical Signs, Symptoms or Conditions135
- Eye Injury6
- Corneal Edema5
- Visual Impairment4
- Capsular Bag Tear3
- Vitreous Floaters3
- Endophthalmitis2
MONARCH models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Monarch 00380659777745Folders and injectors, intraocular lens (iol)270 reports
- MONARCH® 8065977762Folders and injectors, intraocular lens (iol)49 reports
Recent MONARCH adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Crack
A Non-Healthcare Professional reported that, during intraocular lens implantation surgery, crack was observed at the tip of the cartridge and there was no patient harm.Additional information has been requested but is not available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893444 ↗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 14, 2026Difficult to Advance; Material Deformation
A PHYSICIAN REPORTED THAT DURING SURGERY, WHEN THE LENS WAS LOADED INTO THE CARTRIDGE, THE TIP OF THE CARTRIDGE WAS CLOGGED AND THE LENS DID NOT ADVANCE.
Patient problems: Insufficient Information
MAUDE report 25171932 ↗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 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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