MONARCH® III 8065977773Recalls & reported problems
Alcon Laboratories, Inc. · MONARCH III IOL DELIVERY SYSTEM, INJECTOR · Class 1
Quick summary
This Alcon Monarch lens injector, used to place intraocular lenses in the eye, has 338 reports, 15 of them injuries and no deaths. The reports often describe the injector being damaged during use, lenses that do not eject, and parts that bend or get stuck, and a few describe eye injury or blurred vision. Reports in the last 12 months number 11, down from 35 in the previous 12 months. 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
- 338
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 338 adverse event reports that list this exact device (DI 00380659777738), received between Mar 11, 2021 and Aug 14, 2026 — classified as 15 injuries, 323 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (176 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Damaged by Another Device176
- Failure to Eject57
- Material Twisted/Bent52
- Difficult to Advance33
- Defective Device17
- Device Contamination with Chemical or Other Material12
- Failure to Advance12
- Inaccurate Delivery8
Patient problems
- No Clinical Signs, Symptoms or Conditions175
- Insufficient Information145
- Eye Injury6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Blurred Vision5
- Corneal Edema5
- Visual Impairment4
- Eye Irritation2
Recent adverse event reports
The 25 most recent of 338 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260164 ↗MalfunctionAug 3, 2026Inaccurate Delivery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50114552 ↗MalfunctionMar 30, 2026Difficult to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IN SEVERAL INSTANCES OF THE SCREW THREAD GETTING CAUGHT. THE SURGERY COMPLETED WITHOUT ANY ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24715433 ↗MalfunctionFeb 27, 2026Difficult to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED AN ISSUE THAT OCCURRED DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE. WHEN THE LENS WAS BEING INJECTED INTO THE EYE, THE LOADER BECAME STUCK, PREVENTING PROPER ADVANCEMENT OF THE LENS. THEY HAD TO USE ANOTHER LENS TO COMPLETE THE SURGERY. THE REPORTER INDICATED THAT THE LOADER WAS THE MAIN SOURCE OF THE PROBLEM. ADDITIONAL INFORMATION WAS RECEIVED, PROVIDING FURTHER DETAILS ABOUT THE REPORTED EVENT. THE LENS WAS HALFWAY OUT OF THE CARTRIDGE DURING INSERTION; IT TOUCHED THE PATIENT'S EYE BUT DID NOT ENTER THE EYE BECAUSE THE LOADER WAS STUCK. THE SURGERY WAS COMPLETED ON SAME DAY USING A COMPANY LENS OF SAME MODEL AND DIOPTER VALUE AS A REPLACEMENT. THERE WAS NO PATIENT HARM. ACCORDING TO THE SURGEON THE EVENT OCCURRED DUE TO LOADER MALFUNCTION, AS IT GOT STUCK AND DID NOT ADVANCE CORRECTLY. THE SURGEON ALSO NOTED THAT NO OTHER ISSUES WERE OBSERVED DURING IMPLANTATION, AND THERE WAS NO IMPACT TO EITHER THE NOZZLE OR THE IOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469986 ↗MalfunctionFeb 26, 2026Device Damaged by Another Device
A PHYSICIAN REPORTED THAT THE PATIENT UNDERWENT INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY. DURING IMPLANTATION THE INJECTOR PLUNGER PINCHED THE IOL HAPTIC WITHIN THE CARTRIDGE NOZZLE. AS THE PLUNGER ADVANCED FURTHER, THE HAPTIC WAS SEVERED. THE DAMAGED IOL WAS REMOVED AND REPLACED WITH AN IDENTICAL MODEL. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED, NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24456649 ↗MalfunctionFeb 3, 2026Inaccurate Delivery
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR FAILED TO DELIVER THE IOL. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY USING A NEW INJECTOR.
Patient problems: Insufficient Information
MAUDE report 24247658 ↗MalfunctionJan 5, 2026Difficult to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE THREADS WERE TOO TIGHT AND HARD TO USE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED ON SAME DAY AND THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 23955892 ↗MalfunctionDec 31, 2025Inaccurate Delivery; Device Damaged by Another Device; Inaccurate Delivery; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING PHACOEMULSIFICATION SURGERY, WHILE PREPARING FOR IMPLANTATION OF IOL (INTRAOCULAR LENS) WITH COMPANY INJECTOR THE PLUNGER INCORRECTLY POSITIONED THE LENS, WHICH LED TO THE IOL BEING PINCHED AND DEFORMED IN THE NARROW PART OF THE COMPANY CARTRIDGE, FOLLOWED BY THE DETACHMENT OF A HAPTIC ELEMENT AS THE LENS EXITED THE CARTRIDGE. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER UNSPECIFIED LENS WITH SAME DIOPTRIC POWER AVAILABLE IN THE CLINIC WAS IMPLANTED IN THE PATIENT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23933969 ↗MalfunctionNov 28, 2025Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL DELIVERY TIP WAS DAMAGED.
Patient problems: Insufficient Information
MAUDE report 23671098 ↗MalfunctionNov 26, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT WHILE PREPARATION FOR INTRAOCULAR (IOL) PROCEDURE, THE INJECTOR PART WAS MISALIGNED. THE INJECTOR HAD A BENT INTERNAL METAL PART (ROD) AND DID NOT PERFORM THE FUNCTION OF PUSHING THE LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 23657492 ↗MalfunctionNov 4, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL NOTICED THAT THE INJECTOR WAS BENT BEFORE USING, SO IT WAS NOT ANYWHERE NEAR A LENS OR AN EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465565 ↗MalfunctionOct 24, 2025Inaccurate Delivery; Inaccurate Delivery
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE INJECTOR SHOWED RESISTANCE WHEN INJECTING THE IOLS. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT HARM. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23378731 ↗MalfunctionOct 24, 2025Inaccurate Delivery; Inaccurate Delivery
A NONHEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR SHOWED RESISTANCE WHEN INJECTING THE IOLS. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT, THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT HARM. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23377055 ↗MalfunctionSep 5, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS INJECTED INTO THE EYE, A SCRATCH WAS OBSERVED ON ITS SURFACE. THE LENS WAS REMOVED DURING THE SAME PROCEDURE, AND A SUBSEQUENT SECOND LENS WAS IMPLANTED. THE SECOND LENS ALSO SHOWED A SCRATCH IN THE SAME LOCATION. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE WOUND DID NOT NEED TO BE ENLARGED, AND NO ADDITIONAL STITCHES WERE REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT BOTH LENSES HAD A SCRATCH IN THE SAME PERIPHERAL AREA AT THE BOTTOM OF THE LENS. THE SECOND IOL REMAINED IN THE EYE. A COMPANY CARTRIDGE AND HANDPIECE WERE USED.
Patient problems: Insufficient Information
MAUDE report 22978102 ↗MalfunctionJul 30, 2025Device Damaged by Another Device; Difficult to Advance; Device Damaged by Another Device; Difficult to Advance
A NURSE REPORTED THAT THE DEVICE JAMMED AND DID NOT OPERATE SMOOTHLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT, AFTER ATTACHING THE CARTRIDGE, THERE WAS A PROBLEM WITH MOVING THE PLUNGER. THE PRODUCT DID NOT COME INTO CONTACT WITH THE PATIENT. THE ISSUE OCCURRED BEFORE THE PROCEDURE. THE SURGERY WAS A CATARACT REMOVAL AND PROCEDURE WAS COMPLETED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22664403 ↗MalfunctionJul 4, 2025Product Quality Problem; Material Twisted/Bent; Product Quality Problem; Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER WENT ABOVE THE LENS. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, IN SURGEONS OPINION THE EVENT WAS CAUSED DUE TO DEFECTIVE LOADER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22402864 ↗MalfunctionJul 3, 2025Difficult to Advance; Difficult to Advance
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PLUNGER COULD NOT BE PULLED OUT. ROTATING THE KNOB, THE INJECTOR HEAD DID NOT MOVE, AND THE IOL COULD NOT BE IMPLANTED. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22395761 ↗MalfunctionMay 23, 2025Product Quality Problem; Device Damaged by Another Device; Product Quality Problem; Device Damaged by Another Device
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER WAS UNEVEN AND SCRATCHES THE OPTICAL SURFACE OF IOL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22077817 ↗MalfunctionMay 12, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NURSE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE FIRST LENS IMPLANTED HAD A SCRATCH IN THE CENTER OF THE OPTIC, THE SECOND LENS IMPLANTED HAD THE REAR HAPTIC SHEARED OFF. THERE WAS PATIENT DISCOMFORT DURING PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, SURGEON STATED THAT THE COMPANY LENS INSERTERS WERE FAULTY. SURGERY NOT COMPLETED. LENS UNABLE TO BE PLACED. TWO LENSES WERE INSERTED AND REMOVED.
Patient problems: Eye Irritation
MAUDE report 22004732 ↗MalfunctionMay 12, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NURSE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE FIRST LENS IMPLANTED HAD A SCRATCH IN THE CENTER OF THE OPTIC, THE SECOND LENS IMPLANTED HAD THE REAR HAPTIC SHEARED OFF. THERE WAS PATIENT DISCOMFORT DURING PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND SURGEON STATED THAT THE COMPANY LENS INSERTERS WERE FAULTY. SURGERY NOT COMPLETED. LENS UNABLE TO BE PLACED. TWO LENSES WERE INSERTED AND REMOVED.
Patient problems: Eye Irritation
MAUDE report 22002133 ↗MalfunctionMay 5, 2025Difficult to Advance; Difficult to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT A CUSTOMER OPTED TO REPLACE ALL MONARCH IV INSERTERS (50 IN TOTAL) DUE TO ISSUES WITH IOL DAMAGE. THE REPLACED MONARCH III INSERTERS HAD SIGNIFICANT ISSUES WITH INTERNAL FRICTION ON THE SHOOTER PIN SHAFT AND OR FRICTION OR COMPLETE JAMMING OF THE THREADS. THERE WAS QUALITY ISSUES WITH NO LESS THAN 13 MONARCH III INSERTERS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21959136 ↗MalfunctionApr 30, 2025Device Damaged by Another Device; Material Twisted/Bent; Device Damaged by Another Device; Material Twisted/Bent
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS THAT HAS A SMALL DEFECT NOTED AFTER BEING INSERTED INTO THE EYE. THEY TOOK THE INSERTER OUT OF ROTATION AND FLAGGED IT. THE LENS WAS EXPLANTED IN THE INITIAL PROCEDURE AND PATIENT DID WELL WITHOUT ANY COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936439 ↗MalfunctionApr 1, 2025Difficult to Advance; Difficult to Advance
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE SURGEON FELT RESISTANCE WITH COMPANY INJECTOR WHEN ATTEMPTING TO INSERT THE IOL, THEY STOPPED, REPLACED THE INJECTOR, CARTRIDGE AND GOT A NEW LENS AND PROCEEDED WITHOUT PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21737872 ↗MalfunctionMar 27, 2025Device Damaged by Another Device; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS (IOL) SCRATCHED IN THE MIDDLE OF THE OPTIC BY INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21705933 ↗MalfunctionMar 24, 2025Difficult to Advance; Difficult to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT A CUSTOMER OPTED TO REPLACE ALL MONARCH IV INSERTERS (50 IN TOTAL) DUE TO ISSUES WITH IOL DAMAGE. THE REPLACED MONARCH III INSERTERS HAD SIGNIFICANT ISSUES WITH INTERNAL FRICTION ON THE SHOOTER PIN SHAFT AND OR FRICTION OR COMPLETE JAMMING OF THE THREADS. THERE WAS QUALITY ISSUES WITH NO LESS THAN 13 MONARCH III INSERTERS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21684788 ↗
Other LENS, GUIDE, INTRAOCULAR devices
- MONARCH® III 8065977763Alcon Laboratories, Inc. · LENS, GUIDE, INTRAOCULAR1 recall1,042 reports
- UNFOLDER PLATINUM 1 SERIES 1MTEC30Johnson & Johnson Surgical Vision, Inc. · LENS, GUIDE, INTRAOCULAR524 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.