MONARCH® 8065977762Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00380659777622), received between Jun 1, 2021 and Sep 25, 2026 — classified as 8 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (17 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, 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 ↗
• 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 ↗
• MalfunctionApr 20, 2026Defective Component; Device Damaged by Another Device

  A NURSE REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DAMAGED COMPANY CARTRIDGE CAUSED DAMAGE TO THE IMPLANT. THE COMPANY CARTRIDGE AND LENS CHANGED. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THIS WAS NOT A LENS-RELATED ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24925853 ↗
• MalfunctionFeb 14, 2026Crack

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THERE WERE SEVERAL CRACKED CARTRIDGES. THERE WERE NO PATIENT INJURIES. THE ISSUE HAPPEND WHEN IMPLANTING THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340730 ↗
• MalfunctionNov 19, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED IN DELIVERY SYSTEM. MARK WAS LEFT ON IOL. BELIEVED SCRATCH WAS CAUSED DUE TO CARTRIDGE. ADDITIONAL INFORMATION WAS RECEIVED STATING THE LENS REMAINS IMPLANTED IN THE PATIENT'S EYE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594276 ↗
• MalfunctionNov 7, 2025Particulates; Material Split, Cut or Torn; Particulates; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS IMPLANTATION PROCEDURE, DURING EXAMINATION SOME PARTICLE¿S STRUCTURE AND CRACK LIKE STRUCTURE WAS NOTICED IN THE OPTIC OF THE LENS. THE PATIENT'S IMMEDIATE POST-OP WAS 6/9, AND IT WAS AFFECTING THE VISION. AS PER THE SURGEON'S OPINION IT WAS A LENS BURST DUE TO WHICH THE PATIENT DID NOT RECEIVED ANY DESIRED OUTCOMES. HENCE THE SURGEON PLANNED TO DO AN EXPLANT OF THE LENS. THE CURRENT PATIENT CONDITION WAS SYMPTOMS STILL CONTINUING.

  Patient problems: Insufficient Information; Visual Impairment

  MAUDE report 23494427 ↗
• MalfunctionOct 22, 2025Defective Component; Defective Component

  A HEALTH CARE PROFESSIONAL STATED THAT WHILE INJECTING IOL (INTRAOCULAR LENS) DURING IMPLANTATION THE CARTRIDGE WAS RUPTURED. THE CARTRIDGE'S BEAD WAS IN THE INCISION, ALLOWING IT TO BE ADVANCED RELATIVELY NORMALLY AND PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY ADVERSE EFFECT FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355479 ↗
• MalfunctionOct 2, 2025Defective Component; Device Damaged by Another Device; Defective Component; Device Damaged by Another Device

  A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE COMPANY CARTRIDGE WAS BROKE AND DAMAGING THE LENS. THE SURGERY WAS COMPLETED BY REPLACING THE NEW CARTRIDGE AND LENS. THERE WAS PATIENT CONTACT NOTED HOWEVER NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23199722 ↗
• MalfunctionJun 18, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS SCRATCHED UPON SHOOTING.

  Patient problems: Insufficient Information

  MAUDE report 22285079 ↗
• MalfunctionJun 2, 2025Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, WHEN THE HEALTHCARE PROFESSIONAL HANDLED THE IOL, THE CARTRIDGE CHEWED THE LENS AND AMPUTATED (BROKEN) THE HAPTIC OF THE IOL. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. THE DEFECTIVE IOL WAS NOT IMPLANTED DURING THE SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH AN UNSPECIFIED REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125142 ↗
• MalfunctionApr 2, 2025Crack; Device Damaged by Another Device; Crack; Device Damaged by Another Device

  A PHYSICIAN REPORTED THAT DURING SURGERY REPORTED THAT THE CARTRIDGE HAD A CRACK AND THEREFORE DAMAGED THE INTRAOCULAR LENS (IOL). SO, THE LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THE PRODUCT DEFECT WAS DETECTED WHEN THE LENS WAS INSERTED INTO THE CARTRIDGE AND THUS DURING THE PROCEDURE. THERE WAS NO CONTACT WITH THE PATIENT. TO COMPLETE THE SURGERY, A DIFFERENT LENS AND CARTRIDGE WERE THEN USED ON THE SAME DAY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS BELONG TO THE EVENT CARTRIDGE HAD A CRACK AND THEREFORE DAMAGED THE INTRAOCULAR LENS (IOL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21754033 ↗
• InjuryFeb 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AN ACCOUNT MANAGER REPORTED WITH A DESCRIPTION OF CRACK ON LENS AFTER IMPLANTATION. LENS WAS EXPLANTED IN A INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AS SURGEON ATTEMPTED TO IMPLANT A COMPANY +29.5 IOL USING A COMPANY CARTRIDGE, BUT THE LENS WAS FOUND TO BE FRACTURED NEAR THE OPTIC. AFTER CONSULTING ANOTHER PHYSICIAN, THE LENS WAS REMOVED AND REPLACED WITH ANOTHER COMPANY +29.5 USING A CARTRIDGE (UNCERTAIN IF IT WAS THE SAME ONE). HOWEVER, THE SECOND LENS ALSO SHOWED A FRACTURE NEAR THE OPTIC CENTER. DUE TO IRIS TRAUMA FROM THE FIRST LENS REMOVAL AND NO ADDITIONAL +29.5 IOLS AVAILABLE, THE DECISION WAS MADE TO LEAVE THE FRACTURED LENS IN SITU AND CLOSE THE CASE. ONE WEEK POST-OP, THE PATIENT REPORTED 20/80 VISION, WITH CORNEAL EDEMA LIKELY CONTRIBUTING, POSSIBLY DUE TO ENDOTHELIAL DAMAGE, IRIS TRAUMA, OR THE FRACTURED OPTIC.

  Patient problems: Corneal Edema; Corneal Endothelial Cell Loss; Eye Injury; Visual Impairment

  MAUDE report 21440702 ↗
• MalfunctionFeb 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS CRACKED. SURGEON FEELS CARTRIDGE HAD SOME ISSUE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 3 OF 4 FILES.

  Patient problems: Insufficient Information

  MAUDE report 21433411 ↗
• MalfunctionFeb 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS CRACKED. SURGEON FEELS CARTRIDGE HAD SOME ISSUE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 2 OF 4 FILES.

  Patient problems: Insufficient Information

  MAUDE report 21432811 ↗
• MalfunctionFeb 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS CRACKED. SURGEON FEELS CARTRIDGE HAD SOME ISSUE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 1 OF 4 FILES.

  Patient problems: Insufficient Information

  MAUDE report 21431382 ↗
• MalfunctionJan 14, 2025Difficult to Insert; Difficult to Insert

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE INCISION WAS NOT ENLARGED USING THE CARTRIDGE. HENCE THE LENS WAS NOT IMPLANTED IN THE PATIENT'S EYE, IT WAS ONLY HALFWAY INJECTED OUT OF DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 21147087 ↗
• MalfunctionOct 28, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE, THE HAPTICS WAS BROKEN WHEN EXITING CARTRIDGE DURING INJECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20543569 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD CAPSULE RUPTURE, SO THAT VITRECTOMY WAS PERFORMED. SUBSEQUENTLY THE PATIENT DEVELOPED LATE-ONSET ENDOPHTHALMITIS. THE PATIENT ALSO PRESENTED WITH HYPEREMIA, CORNEAL EDEMA, KERATIC PRECIPITATES, CELL, FLARE, FIBRIN, ANTERIOR CHAMBER EMPYEMA, HAZY VITREOUS AND DIFFICULTY IN FUNDUS VISUALIZATION. AFTER THE SURGERY THERE WAS NO UNCOMFORTABLE FEELING TO THE PATIENT. THE PATIENT WAS TREATED WITH UNSPECIFIED CORTICOSTEROID EYE DROPS, UNSPECIFIED ANTIBIOTIC EYE DROPS, UNSPECIFIED NON-STEROIDAL ANTI-INFLAMMATORY DRUGS EYE DROPS AND A STEROID SUBCONJUNCTIVAL INJECTION. AS PER THE SURGEON, CAPSULE RUPTURE, STITCHES, AND NUCLEAR FALL OCCURRED WERE NOT RELATED TO IOL. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Edema; Endophthalmitis; Fibrosis; Hypopyon; Iritis; Keratitis; Red Eye(s); Vitreous Floaters

  MAUDE report 20513150 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, POSTERIOR CAPSULE RUPTURED AND SO THE VITRECTOMY WAS PERFORMED. AFTER THE SURGERY, THE PATIENT REPORTED NO UNCOMFORTABLE FEELINGS. AFTER SURGERY THE PATIENT DEVELOPED INFECTIOUS ENDOPHTHALMITIS. THE PATIENT ALSO HAD CORNEAL EDEMA, CELLS AND FLARING, FIBRIN, KERATIC PRECIPITATES AND VITREOUS OPACITY. THE PATIENT WAS TREATED WITH UNSPECIFIED CORTICOSTEROID EYE DROPS, UNSPECIFIED ANTIBIOTIC EYE DROPS, UNSPECIFIED NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) EYE DROPS. ACCORDING TO THE SURGEON, THE CAPSULE RUPTURE WAS NOT RELATED TO THE IOL. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Edema; Endophthalmitis; Fibrosis; Iritis; Keratitis; Vitreous Floaters

  MAUDE report 20513136 ↗
• MalfunctionMar 21, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL DAMAGED. THE SURGEON FELT IT WAS FROM THE CARTRIDGE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER DUPLICATE LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18949560 ↗
• MalfunctionMar 4, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED AND NOTICED UPON IMPLANTATION BY THE CARTRIDGE. THE CARTRIDGE THAT WAS USED IN THE EVENT HAS TO BE INSPECTED FURTHER AND LENS WAS KEPT IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826269 ↗
• MalfunctionFeb 9, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED WITH A DESCRIPTION OF OBSERVED SCRATCHES ON A LENS WHEN SURGEON IMPLANTED LENS. THE CUSTOMER BELIEVES IT IS DUE TO THE CARTRIDGE THAT WAS USED. THE SURGEON MENTIONED THAT THIS HAS HAPPENED ON MORE THAN ONE OCCASION. ADDITIONAL INFORMATION IS RECEIVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18674676 ↗
• MalfunctionDec 27, 2023Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE SCRATCH ON CARTRIDGE WAS FOUND. HOWEVER, IMPLANT SUCCEEDED AND THE SURGERY WAS COMPLETED WITHOUT ANY ISSUE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18397287 ↗
• MalfunctionNov 16, 2023Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LOADING AREA OF THE CARTRIDGE WAS SMALL, MAKING IT DIFFICULT FOR FORCEPS TO PUSH IN, AND THE TIP WAS SMALL, MAKING IT DIFFICULT FOR INTRAOCULAR LENS (IOL) TO BE INJECTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148555 ↗
• MalfunctionNov 16, 2023Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LOADING AREA OF THE CARTRIDGE WAS SMALL, MAKING IT DIFFICULT FOR FORCEPS TO PUSH IN, AND THE TIP WAS SMALL, MAKING IT DIFFICULT FOR INTRAOCULAR LENS (IOL) TO BE INJECTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148544 ↗