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 Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The used company cartridge was returned loose in the 10-count carton for lot 15885159.Two unopened company cartridges were also returned in the carton.One was selected for evaluation.The used company cartridge was microscopically examined.Inadequate viscoelastic was observed in the returned used cartridge.Only a small ring of viscoelastic was observed mid-body.No other viscoelastic was observed.The cartridge nozzle was cracked along top.The crack extended into the thinner tip where an aneurysm formed and tore.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.One of the returned unopened company cartridges was selected for evaluation.The company cartridge was microscopically examined with no damage or abnormalities observed.The cartridge was functionally tested per the ifu.The cartridge was filled with viscoelastic per the ifu (instructions for use).The lens was loaded and biased down.The lens was advanced making sure the plunger was in the correct position in contact with the trailing optic edge.No lens or cartridge damage was observed after the lens delivery.The company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.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.It is unknown if a qualified handpiece and viscoelastic were used.The root cause for the observed damage appears to be related to a failure to follow the ifu.Inadequate viscoelastic was observed in the cartridge.Only a small ring of viscoelastic was observed mid-body.No other viscoelastic was observed.The cartridge nozzle was cracked along top.The crack extended into the thinner tip where an aneurysm formed and tore.Functional and dye stain testing was conducted with the unopened sample with acceptable results.No lens or cartridge damage was observed after the lens delivery.The ifu instructs to completely fill the cartridge with ovd (viscosurgical device) 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 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.The two distinct areas of damage would indicate a progressive change that occurred as the lens was advanced.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: 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: 23355479
• Report Number: 1119421-2025-02734
• Device Sequence Number: 9202711
• Product Code: MSS
• UDI-Device Identifier: 00380659777622
• UDI-Public: (01)00380659777622(17)270711(11)240712(10)15885159
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: 15885159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2024
• 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 IQ PANOPTIX TORIC TRIFOCAL IOL.
• Patient Sex: Unknown