MONARCH® III 8065977763Recalls & reported problems
Alcon Laboratories, Inc. · The Monarch® "D" Cartridge is a single-use polypropylene cartridge for posterior chamber IOL delivery · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alcon Monarch III cartridge is the subject of 1,031 adverse event reports, which mention no deaths and 50 injuries. Many reports describe cracked, contaminated or damaged cartridges, and some describe lenses scratched during implantation. 1 open recall, started in November 2024, concerns a molding defect inside the cartridge that can scratch the lens during delivery.
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
- 1,042
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,042 adverse event reports that list this exact device (DI 00380659777639), received between Mar 2, 2021 and Sep 28, 2026 — classified as 50 injuries, 992 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (326 reports).
1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
Most reported problems
Device problems
- Device Damaged by Another Device326
- Device Contamination with Chemical or Other Material312
- Crack154
- Scratched Material80
- Material Split, Cut or Torn60
- Defective Device46
- Defective Component36
- Break28
Patient problems
- No Clinical Signs, Symptoms or Conditions534
- Insufficient Information469
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available20
- Eye Injury13
- Endophthalmitis6
- Foreign Body In Patient5
- Foreign Body Sensation in Eye5
- Posterior Capsule Opacification4
Recent adverse event reports
The 25 most recent of 1,042 reports, 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 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 ↗MalfunctionAug 10, 2026Difficult to Advance
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, the cartridge did not stay seated and locked into place during advancement of the lens into the patient's eye. The lock was expected to snap into place, but it did not. The surgeon noted that the patient had a very shallow amount of depth for reinsertion of the lens. The cartridge did not allow the product to advance properly and was very stiff. During lens insertion, an audible click was heard, and the cartridge backed out slightly from the plunger.Additional information was requested but was not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50195025 ↗MalfunctionAug 5, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50141952 ↗MalfunctionJun 9, 2026Device Damaged by Another Device
A FACILITY REPRESENTATIVE ON BEHALF OF THE FACILITY REPORTED THAT SCRATCH NOTICED UPON IMPLANTATION. THERE WAS NO HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. LENS WAS LEFT IMPLANTED. 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 25438740 ↗MalfunctionJun 3, 2026Scratched Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, A SCRATCH WAS OBSERVED ON THE POSTERIOR SURFACE OF THE LENS AFTER IMPLANTATION. THE PROCEDURE WAS COMPLETED ON THE SAME DAY, AND THE LENS WAS REPLACED WITH THE SAME MODEL AND POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25376019 ↗MalfunctionJun 2, 2026Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION IN PATIENT'S RIGHT EYE, A SCRATCH WAS OBSERVED ON THE POSTERIOR SIDE OF THE IOL AFTER IT WAS IMPLANTED. THE LENS WAS NOT REMOVED FROM THE EYE, IT REMAINS IMPLANTED. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM. ACCORDING TO THE SURGEON, SOMETHING PHYSICALLY SCRATCHED THE POSTERIOR SIDE OF THE IOL. 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 25362073 ↗MalfunctionJun 2, 2026Scratched Material
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION IN PATIENT'S RIGHT EYE, A SCRATCH WAS OBSERVED ON THE POSTERIOR SIDE OF THE IOL AFTER IT WAS IMPLANTED. THE LENS WAS NOT REMOVED FROM THE EYE, IT REMAINS IMPLANTED. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM. ACCORDING TO THE SURGEON, SOMETHING PHYSICALLY SCRATCHED THE POSTERIOR SIDE OF THE IOL. 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 25361623 ↗MalfunctionJun 2, 2026Scratched Material
A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS OBSERVED ON THE POSTERIOR SIDE OF THE LENS AFTER IMPLANTED. THE LENS WAS NOT REMOVED AND REMAINED IMPLANTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. ACCORDING TO THE SURGEON, SOMETHING PHYSICALLY SCRATCHED THE POSTERIOR SIDE OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25361621 ↗MalfunctionJun 2, 2026Scratched Material
A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, A SCRATCH WAS OBSERVED ON THE POSTERIOR SIDE OF THE LENS AFTER IT WAS IMPLANTED. THE LENS WAS INSERTED AND NOT REMOVED, AND IT WAS LEFT IMPLANTED. THE PROCEDURE WAS COMPLETED THE SAME DAY. SOMETHING PHYSICALLY SCRATCHED THE POSTERIOR SIDE OF THE IOL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25360424 ↗MalfunctionJun 2, 2026Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, A SCRATCH WAS OBSERVED ON THE POSTERIOR SIDE OF THE LENS AFTER IT WAS IMPLANTED. THE LENS WAS INSERTED AND NOT REMOVED, AND IT WAS LEFT IMPLANTED. THE PROCEDURE WAS COMPLETED THE SAME DAY. IN THE SURGEON OPINION SOMETHING PHYSICALLY SCRATCHED THE POSTERIOR SIDE OF THE IOL. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25360284 ↗MalfunctionMay 25, 2026Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GOT SCRATCHED. ADVANCED IN DELIVERY SYSTEM PLUNGER WENT BETWEEN TWO HAPTICS. PRODUCT WAS GOOD, ADVANCING FAILED WHICH CAUSED THE ISSUE OF POSITION TO COMPROMISE LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS WAS OPENED BY THE CIRCULATOR NURSE AFTER VERIFICATION WITH THE DOCTOR. THE LENS CONTACTED A NON-COMPANY OVD AND WAS NOTED TO BE PRELOADED MIDWAY IN THE COMPANY CARTRIDGE. THE LENS WAS HANDLED BY THE SCRUB TECHNICIAN USING NON-COMPANY FORCEPS, AND THE LENS WAS LIFTED BY THE HAPTIC WITH FORCEPS AND THEN FOLDED WITH STERILE GLOVES USING FORCEPS TO PLACE THE LENS INTO THE CARTRIDGE. THE LENS WAS ADVANCED FURTHER INTO THE CARTRIDGE WITH FORCEPS, WITH THE FORCEPS TIPS CLOSED AND POSITIONED TOWARDS THE WALLS OF THE CARTRIDGE DURING THE PROCESS TO SAFELY ADVANCE THE LENS, AND IT WAS THEN ADVANCED FURTHER WITH THE INJECTOR OR HANDPIECE TO COMPLETE THE PROCESS. THE DOCTOR ADVISED THE TECHNICIAN TO ENSURE THAT THE INJECTOR OR HANDPIECE DID NOT PASS BETWEEN THE HAPTICS AND THE LENS DURING ADVANCEMENT, AS THIS WAS REPORTED TO BE THE REASON THE LENS BECAME SCRATCHED
Patient problems: Insufficient Information
MAUDE report 25270746 ↗MalfunctionMay 21, 2026Crack
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OVER THE PREVIOUS 5-6 MONTHS THEY HAD EXPERIENCED CONSISTENT ISSUES WITH THE CARTRIDGES SPLITTING DURING INJECTION AT AN APPROXIMATE RATE OF 50%. THIS HAD LED THEM TO CREATE A TEMPORARY AUTONOMY CONSIGNMENT, WITH THE AUTONOMY LENSES INJECTING CORRECTLY ONLY ABOUT 50% OF THE TIME AS WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 1 OF 2 FILES.
Patient problems: Insufficient Information
MAUDE report 25241595 ↗
Other LENS, GUIDE, INTRAOCULAR devices
- UNFOLDER PLATINUM 1 SERIES 1MTEC30Johnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR524 reports
- MONARCH® III 8065977773Alcon Laboratories, Inc. · LENS, GUIDE, INTRAOCULAR338 reports
- UNFOLDER EMERALD EMERALDCJohnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR250 reports
- UNFOLDER SILVER PSCSTJohnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR66 reports
- MONARCH® II 8065977758Alcon Laboratories, Inc. · LENS, GUIDE, INTRAOCULAR22 reports
- ONE SERIES ULTRA 1VIPR30Johnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR8 reports
- UNFOLDER EMERALD EMERALDTJohnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR8 reports
- Bausch + Lomb AI-28Bausch & Lomb Incorporated · Lens, Guide, Intraocular3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.