MONARCH IIIRecalls & 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
1 open recall names at least one MONARCH III model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,380
- Deaths reported
- 0
- Injuries reported
- 65
- Recalls
- 1
We found 2 models of MONARCH III by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 1,380 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2021 and Sep 28, 2026 — classified as 65 injuries, 1,315 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (502 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
MONARCH III recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 13, 2024Open, Classified
Increase in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.
Z-0835-2025 · Root cause: Process design · Recall details · FDA record ↗
Most reported MONARCH III problems
Device problems
- Device Damaged by Another Device502
- Device Contamination with Chemical or Other Material324
- Crack154
- Scratched Material84
- Failure to Eject77
- Defective Device63
- Material Split, Cut or Torn60
- Difficult to Advance57
Patient problems
- No Clinical Signs, Symptoms or Conditions709
- Insufficient Information614
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available25
- Eye Injury19
- Blurred Vision8
- Corneal Edema8
- Visual Impairment8
- Endophthalmitis7
MONARCH III models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MONARCH® III 8065977763LENS, GUIDE, INTRAOCULAR1 recall1,042 reports
- MONARCH® III 8065977773LENS, GUIDE, INTRAOCULAR338 reports
Recent MONARCH III adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Crack
A non-health care professional reported with the description of cracked cartridges.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 50915649 ↗MalfunctionSep 22, 2026Scratched Material
A Nurse reported with a description of Inner surface of cartridge caused scratches to the IOL (Intraocular lens).Additional information has been requested, but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50855623 ↗MalfunctionSep 18, 2026Scratched Material
Patient problems: Insufficient Information
MAUDE report 50828409 ↗MalfunctionSep 17, 2026Scratched Material
A non-healthcare professional reported that, during cataract surgery with an intraocular lens implant procedure, the lens was observed to be scratched. There was no patient contact. Additional information has been requested and received stating that the lens was explanted during initial procedure, and a new unspecified lens was inserted. The procedure was completed the same day.
Patient problems: Insufficient Information
MAUDE report 50805036 ↗MalfunctionSep 16, 2026Scratched Material
A non-healthcare professional reported that during an intraocular lens (IOL) implant procedure, a scratch on the lens was noticed. There was no patient contact. Additional information has been requested and received stating that they observed a scratch was noticed on backside of lens after insertion. Subsequently the lens was removed during initial procedure and completed with another lens on the same day. In the surgeon¿s opinion, cartridge caused or contributed to the event. This issue occurred multiple times among many patients.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790176 ↗MalfunctionSep 15, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775540 ↗MalfunctionSep 15, 2026Device Damaged by Another Device; Material Deformation
A physician reported that, during an intraocular lens (IOL) implantation procedure, while advancing the lens through the cartridge, the cartridge tip was found to be damaged. When the physician tried to remove the lens, it was also damaged therefore, another unspecified lens had to be used.Additional information has been requested and received stating that the surgery completed on the same day and there was no patient contact.Additional information has been requested but no information is available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775193 ↗MalfunctionSep 15, 2026Device Damaged by Another Device
A nonhealth care professional reported that during the intraocular lens (IOL) implantation surgery, the cartridges caused marks on lens.Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50773131 ↗MalfunctionSep 2, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564681 ↗MalfunctionSep 2, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564404 ↗MalfunctionSep 2, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50559340 ↗MalfunctionAug 14, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260164 ↗MalfunctionAug 12, 2026Particulates; Defective Component
A healthcare professional reported that, during an intraocular lens implantation surgery, while using the company lens with the cartridge, an imperfection was observed inside the cartridge. When the lens was injected, some material was introduced into the eye together with the lens.Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50223806 ↗MalfunctionAug 12, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221636 ↗MalfunctionAug 12, 2026Device Damaged by Another Device; Material Deformation
A non-health care professional reported that during an intraocular lens (IOL) implant procedure, it was noticed that the tip of company cartridge was defective. It had loose sharp plastic at the end that caused lens damage. There were no patient contact and no harm to the patient. No further information is expected as reporter unwilling to provide additional information.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50219295 ↗
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
- ClearCut17 models · 531 reports · 13 recalls
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.
How reports and recalls are matched · Editorial policy · Report an error on this page