MONARCH® II 8065977758Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00380659777585), received between Jun 16, 2021 and Nov 7, 2025 — classified as 6 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (7 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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CARTRIDGE CHEWED THE LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER UNSPECIFIED LENS WITHOUT ANY HARM TO THE PATIENT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497329 ↗
• MalfunctionAug 5, 2025Defective Component; Defective Component

  THE EVENT REPORT FOR THIS FILE WAS RECEIVED FROM THE BRAZILIAN HEALTH AUTHORITY REPORTING WITH A DESCRIPTION OF COMPANY CARTRIDGE APPARENTLY FLATTENED AND CANNOT BE USED (INTRAOCULAR LENS DOES NOT FIT).

  Patient problems: Insufficient Information

  MAUDE report 22715028 ↗
• MalfunctionOct 1, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF ON IMPLANTATION USING THE CARTRIDGE THERE WAS A SMALL CRACK IN THE OPTIC. THE LENS WAS LEFT IN THE PATIENT EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20342972 ↗
• MalfunctionJul 24, 2024Failure to Eject; Failure to Eject

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS GOT STUCK IN THE INSERTER HALFWAY IN THE EYE, LENS HAD TO BE REMOVED. NEW LENS WAS INSERTED. AS PER THE PHYSICIANS OPINION, THE EVENT OCCURRED DUE TO THE INSERTER AND THE CARTRIDGE. NO PATIENT HARM. SYMPTOMS RESOLVED. PATIENT WAS HAPPY WITH THE OUTCOME OF THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818502 ↗
• InjuryJun 25, 2024Failure to Eject; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE HAPTIC DIDN'T COME THROUGH CARTRIDGE CORRECTLY AND HAD TO ENLARGE INCISION LENS WAS INSERTED. THE PROCEDURE COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Injury

  MAUDE report 19604759 ↗
• MalfunctionMay 17, 2024Material Twisted/Bent; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE LENS HAPTIC REMAINED BENT AND DID NOT OPEN DUE TO CARTRIDGE SO ANOTHER LENS WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT HAPTIC BENT AND NOT EXPANDING DUE TO CARTRIDGE MALFUNCTION. IOL HAD TO BE EXPLANTED AND USED THE REPLACEMENT LENS. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339580 ↗
• MalfunctionMay 8, 2024Break; Failure to Eject; Break; Failure to Eject

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE MOMENT OF POSITIONING THE INTRAOCULAR LENS, IT IS ADHERED TO THE SUSPENSION CARTRIDGE, DAMAGE TO THE INTRAOCULAR SUPPORT FIN, SO THE PATIENT'S LENS WAS REPLACED BY THE SURGEON'S INDICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19268031 ↗
• MalfunctionApr 8, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED CARTRIDGE SCRATCHED THE LENS.

  Patient problems: Insufficient Information

  MAUDE report 19058906 ↗
• MalfunctionFeb 13, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) BACK HAPTIC RIPPED. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED IN SURGEON'S OPINION THE CARTRIDGE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694086 ↗
• MalfunctionNov 28, 2023Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CARTRIDGE DIAMETER WAS LARGER, MAKING IT DIFFICULT TO INCISE SCALPEL. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18216120 ↗
• MalfunctionNov 28, 2023Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CARTRIDGE DIAMETER WAS LARGER, MAKING IT DIFFICULT TO INCISE SCALPEL. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18216117 ↗
• MalfunctionSep 27, 2023Defective Device; Device Damaged by Another Device; Defective Device; Device Damaged by Another Device

  UPON FURTHER REVIEW THIS COMPLAINT WAS REASSESSED AND CONFIRMED THAT, THIS EVENT DOES NOT MEET CRITERIA FOR REPORTING AS A REPORTABLE MALFUNCTION AS THERE WAS NO PATIENT CONTACT WITH THE PRODUCT AND THE ISSUE WAS NOTED DURING LOADING/PRIMING. NO FURTHER REGULATORY REPORTS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17823216 ↗
• InjurySep 11, 2023Unintended Ejection; Unintended Ejection

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SUDDEN, UNEXPECTED AND FORCEFUL EJECTION OF IOL FROM THE CARTRIDGE RUPTURED THE POSTERIOR LENS CAPSULE AND LODGED IN THE VITREOUS, REQUIRING ANOTHER EYE DOCTOR SURGERY TO RETRIEVE IT. RETRIEVED LENS OPTIC AND A HAPTIC ON RECOVERY WERE FOUND TO BE BENT. THEY WERE LIKELY MANGLED BY UNDUE PRESSURE FROM A MISMATCH OR DEFECT IN THE BARREL AND THE IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED DURING REMOVAL OF NATURAL LENS, ANTERIOR CAPSULE BROKE AND TEAR EXTENDED AROUND TO THE POSTERIOR CAPSULE BRINGING VITREOUS INTO THE ANTERIOR CHAMBER. LIMITED ANTERIOR VITRECTOMY WAS PERFORMED WITHOUT DIFFICULTY. AS LENS WAS BEING INSERTED, IT SUDDENLY JUMPED OUT AND FELL INTO THE VITREOUS. PATIENT THEN SENT TO RETINA SPECIALIST FOR VITRECTOMY AND REPOSITIONING OF IOL FROM RETINA TO SULCUS. PARS PLANA VITRECTOMY WAS PERFORMED, IOL WAS RETRIEVED FROM THE VITREOUS AND EXPLANTED. ANOTHER IOL WAS GENTLY PLACED, WOUND WAS SUTURED TO CLOSE. IOL WAS CENTERED NICELY.

  Patient problems: Insufficient Information

  MAUDE report 17718626 ↗
• MalfunctionJul 24, 2023Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, COMPANY CARTRIDGE WAS USED AND NOTICED DIFFUSE BROAD CENTRAL ANTERIOR HAZY SCRATCHES ON INTRAOCULAR SURFACE AND POOR ACUITY. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Visual Impairment

  MAUDE report 17378973 ↗
• MalfunctionJul 24, 2023Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE COMPANY CARTRIDGE WAS USED AND NOTICED DIFFUSE BROAD CENTRAL ANTERIOR HAZY SCRATCHES ON INTRAOCULAR SURFACE AND POOR ACUITY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 17377843 ↗
• InjuryMar 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THEY WERE UNABLE TO SUCCESSFULLY LOAD THE LENS INTO THE CARTRIDGE. THE LENS WAS FINAL LOADED USING THE LONG ANGLE FORCEPS. THEN THE INJECTOR PROBE KEPT PASSING OVER OR UNDER THE IOL WITHOUT ADVANCING IT. THE INJECTOR PLUNGER WAS SLIGHTLY BENT UP. THE LENS WAS INSPECTED AND THERE WERE NO SCRATCHES ON THE LENS. SO THEY ENLARGED THE CORNEAL INCISION TO ABOUT 6MM, AND MANUALLY DELIVERED THE LENS INTO THE ANTERIOR CHAMBER. THEN CLOSED THE INCISION WITH 3 INTERRUPTED 10-0 NYLON SUTURES.

  Patient problems: Eye Injury

  MAUDE report 16598448 ↗
• MalfunctionDec 6, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IN A JOURNAL ARTICLE, NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTED THE PRESENCE OF A CRUST ON ONE OF THE HAPTICS AND THE OPTIC. IT WAS NOT POSSIBLE TO REMOVE THIS MATERIAL FROM THE IOL SURFACE BY IRRIGATION/ASPIRATION. THE LENS WAS BISECTED FOR EXPLANTATION AND EXCHANGED FOR ANOTHER LENS. THE PATIENT WAS LAST SEEN AT THE 6-MONTH VISIT WITH 20/25 UNCORRECTED VISUAL ACUITY. SLIT LAMP EXAMINATION WAS UNREMARKABLE AT THAT TIME. IT WAS REPORTED THAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) PRECIPITATION MIGHT HAVE OCCURRED IN THE CASE REPORTED HERE UNDER DIFFERENT CIRCUMSTANCES, AFTER LENS LOADING INTO THE INJECTOR, OR IMMEDIATELY AFTER INJECTION OF THE LENS INTO THE EYE. RESIDUES FROM CARTRIDGES COATING ARE ALSO A POSSIBILITY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS ARTICLE. THIS REPORT IS FOR 2ND REPORT OUT OF 2 REPORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924263 ↗
• InjuryNov 30, 2022Particulates; Adverse Event Without Identified Device or Use Problem; Particulates; Adverse Event Without Identified Device or Use Problem

  IN A JOURNAL ARTICLE, NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PHYSICIAN NOTED THAT IT WAS DIFFICULT INJECTING THE LENS INTO THE EYE WITH A CRUNCHING SOUND. UPON INSERTION, A WHITE, GRANULAR MATERIAL WAS NOTED IMMEDIATELY ON THE LENS AND IN THE ANTERIOR CHAMBER. ATTEMPTS TO REMOVE THIS MATERIAL BY IRRIGATION AND ASPIRATION WERE ONLY PARTIALLY SUCCESSFUL. THE LENS WAS THEN CUT IN HALF WITH SCISSORS AND REMOVED. VIGOROUS IRRIGATION AND ASPIRATION WAS USED TO REMOVE THE REMAINING OPHTHALMIC VISCOSURGICAL DEVICE (OVD) AND THE WHITE, GRANULAR MATERIAL FROM THE CAPSULAR BAG. SOME OF THIS MATERIAL WAS NOTED IN THE CLEAR CORNEAL WOUND, WHICH COULD NOT BE REMOVED. ANOTHER SAME MODEL LENS WAS THEN INJECTED INTO THE BAG. POSTOPERATIVELY, THE PATIENT INITIALLY DEVELOPED CORNEAL EDEMA AT 1 WEEK. AT 1 MONTH POSTOPERATIVELY, THE LAST TIME THE PATIENT WAS SEEN, THE EYE WAS QUIET, THE CORNEAL EDEMA HAD RESOLVED. IT WAS REPORTED THAT OPHTHALMIC VISCO SURGICAL PRECIPITATION MIGHT HAVE OCCURRED IN THE CASE REPORTED HERE UNDER DIFFERENT CIRCUMSTANCES, AFTER LENS LOADING INTO THE INJECTOR, OR IMMEDIATELY AFTER INJECTION OF

  Patient problems: Corneal Edema

  MAUDE report 15884921 ↗
• InjuryApr 9, 2022Break; Break

  A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS CAME BROKEN FROM THE CARTRIDGE. THE RESULT IS A CAPSULAR TEAR AND A LENS IN THE SULCUS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 14067866 ↗
• InjuryFeb 11, 2022Break; Inaccurate Delivery; Break; Inaccurate Delivery

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE LENS IS LOADED WITH THE HAPTIC STRETCHED AND AN ATTEMPT IS MADE TO ADVANCE IT WITH THE PLUNGER. THIS IS NOT SUCCESSFUL AT FIRST ATTEMPT. VISCOELASTIC IS ADDED AGAIN TO ADVANCE THE LENS SLIGHTLY. IT HARDLY MOVES IN THE CARTRIDGE AND CANNOT BE ADVANCED TO THE END WITH THE PLUNGER. ON FURTHER ATTEMPT TO ADVANCE, THE LENS MOVES ANTERIORLY TO THE OPENING AND IS NOW PLACED IN THE ANTERIOR CHAMBER WITH THE PLUNGER VIA THE EXTENDED 3.0 INCISION. AS THE LENS IS ADVANCED, THE COMPANY CARTRIDGE TEARS LONGITUDINALLY. THE LENS IS IMPLANTED INTO THE SULCUS AND CANNOT BE RETRACTED. THE SHARP EDGE CAUSES A ZONULOLYSIS AT 6 O'CLOCK, SO THAT THE CAPSULE CANNOT ACCOMMODATE THE LENS IN SIZE AND A CAPSULAR TENSION RING IMPLANTATION IS ALSO NOT GOAL-DIRECTED DUE TO THE SIZE OF THE ZONULA LESION. WITH EXTREMELY FLAT ANTERIOR CHAMBER NOW NON COMPANY VISCOELASTIC AND ANOTHER COMPANY VISCOELASTIC IS ENTERED TO EXPLANT THE LENS HAPTIC AGAIN AND FINALLY TO CUT THE EXTREMELY THICK LENS WITH THE LENS SCISSORS, A TRIANGLE IS CUT OUT, THIS WITH VERY FLAT ANTERIOR CHAMBER, HARDLY IN THE ANTERIOR CHAMBER MANEUVERABLE, THEREBY AGAIN AND AGAIN IRIS INCARCERATION, I

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Zonular Dehiscence

  MAUDE report 13513997 ↗
• MalfunctionDec 13, 2021Device Damaged by Another Device; Device Damaged by Another Device

  A CONSUMER REPORTED THAT, DURING INTRAOCULAR LENS IMPLANT (IOL) PROCEDURE, THE CARTRIDGE DAMAGED THE IMPLANT. THERE WAS A PATIENT CONTACT, HOWEVER NO PATIENT HARM WAS NOTED. NO HOSPITALIZATION REQUIRED. THE PROCEDURE WAS COMPLETED AT THE SAME MOMENT BY USING REPLACED IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983057 ↗
• MalfunctionJun 16, 2021Difficult to Advance; Difficult to Advance

  A FACILITY REPRESENTATIVE REPORTED VIA MAIL THAT WHEN TRYING TO INSERT THE IOL IN CARTRIDGE, THE SURGEON FOUND RESISTANCE TO EJECT THE IOL, NOT ALLOWING CONTINUITY. NO OTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009435 ↗