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	Defective Component (2292); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.The reported product lot number was not provided.Lot specific reviews for similar complaints or non-conformances could not be conducted.However, before production release, each device history record is reviewed to ensure that the product met the required specifications and release criteria.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
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.
Additional Manufacturer Narrative
The used company cartridge was returned in the opened pouch.Inadequate viscoelastic was observed in the cartridge.The nozzle is split top center.The split goes from mid-nozzle to the end of the tip.The cartridge had evidence of placement into a handpiece.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The lens was returned loose in the opened monarch pouch.Viscoelastic was observed on the lens.The optic was broken on one edge with a potion removed, not returned.A small scrape was observed near the edge opposition the broken edge.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 and handpiece were indicated with a non-qualified viscoelastic.The root cause appeared to be related to a failure to follow the instruction for use (ifu).Inadequate viscoelastic was observed in the cartridge.The cartridge and lens damage observed may also indicate a plunger override occurred.The returned used company cartridge had a split top center that started mid-nozzle and extended to the end of the tip.The damage on the top of the nozzle started in the thick wall cone area.Unusually high internal forces would be needed to create damage in this area.Damage in the thick cone wall section has been associated with the use of cold viscoelastic.The ifu instructs to use viscoelastic, which has been allowed to come to the operating room temperature.This type of damage may also occur if the lens/plunger are not positioned correctly for advancement the ifu instructs to completely fill the cartridge with ophthalmic viscosurgical devices (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.Important: the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.The handpiece ifu instructs: verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately ½ turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.The manufacturer internal reference number is: (b)(4).

• 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: 23199722
• Report Number: 1119421-2025-02619
• Device Sequence Number: 21151806
• Product Code: MSS
• UDI-Device Identifier: 00380659777622
• UDI-Public: (01)00380659777622(17)271029(11)241030(10)15932607
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K112977
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 15932607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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: ACRYSOF SINGLEPIECE IOL; CENTURION OZIL HANDPIECE; MINIVISC PLUS; MONARCH II, INJECTOR
• Patient Sex: Unknown