MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number	8065977762
Medical Device Problem Codes	Particulates (1451); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Visual Impairment (2138); Insufficient Information (4580)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified the manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Additional information was provided in h.6.And h.11.The product was not returned.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.A qualified lens model/diopter was indicated with a non-qualified handpiece and viscoelastic.The product investigation could not identify a root cause for the reported complaint.The company cartridge was not returned.The lens has not been explanted.The root cause for the reported lens damage may be related to a failure to follow the ifu.A non-qualified handpiece and viscoelastic were indicated.The or temperature was indicated to be 24 degrees.The instructions for use (ifu) instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic visco surgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs: use the company cartridge at operating room temperatures between 18° c (64° f) and 23° c (73° f).If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the company iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.The manufacturer internal reference number is: 2025-84207 h.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C
• Common Device Name: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23494427
• Report Number: 1119421-2025-02868
• Device Sequence Number: 21108757
• Product Code: MSS
• UDI-Device Identifier: 00380659777622
• UDI-Public: (01)00380659777622(17)271216(11)241217(10)15933198
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K112977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065977762
• Device Lot Number: 15933198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 12/17/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AUROVISC OVD; CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC IOL; EPSILON SHOOTER
• Patient Sex: Male