MAUDE Adverse Event Report: Alcon Research, LLC - Huntington MONARCH III IOL Delivery System, Cartridge D; Folders and Injectors, Intraocular Lens (IOL)

Catalog Number	8065977763
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported with the description of cracked cartridges.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Two used company cartridges were returned in opened pouches for lot 16254659.Thiry-one unopened company cartridges for lot 16254659 were also returned.Three samples were randomly selected for evaluation.The two used company cartridges were numbered 1-2 for evaluation purposes.The three unopened company cartridges were opened and numbered 1u- 3u for evaluation purposes.The two used company cartridges were microscopically examined.Viscoelastic was observed in the cartridges.The two cartridge nozzles were cracked bottom right, which split as int entered the thinner tip area.The tips also had moderate stress.The cartridges had evidence of placement into a handpiece.The two used company cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The three unopened company cartridges were microscopically examined with no damage or abnormalities observed.The company cartridges were functionally tested per the instructions for use (ifu).No lens or cartridge damage was observed after the lens deliveries.The three company cartridges were cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The products were reviewed by the principal engineer, manufacturing science & technology.No manufacturing related issues were found.A batch 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 handpiece and viscoelastic were indicated.The lens model/diopter was not provided.It is unknown if qualified lenses were being used.The root cause for the reported damage could not be determined.It is unknown if qualified lenses were being used.Two used company cartridges were returned.The nozzles were cracked on the bottom, which extended into the tip.Top coat dye stain testing was conducted with acceptable results.Three of the unopened company cartridges returned for the reported lot were also evaluated.Functional and dye stain testing was conducted.No lens or cartridge damage was observed after the lens deliveries.Top coat dye stain testing was conducted with acceptable results.Split tips may occur due to: room temperature too cold/cold ophthalmic viscosurgical device (ovd).Plunger advancement speed too fast.Inadequate ophthalmic viscosurgical device (ovd) placed in the cartridge.The lens model/diopters being used were not provided.It is unknown if qualified lenses were used.The instructions for use (ifu) instructs: the monarch¿ intraocular lens delivery system is for implantation of qualified company foldable intraocular lens.No unqualified lenses should be used with the company intraocular lens delivery system.The company cartridges are qualified for use with compatible company handpieces for the surgical implantation of company qualified foldable intraocular lens.Company foldable intraocular lens are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ophthalmic viscosurgical device (ovd)) combination.The use of an unqualified combination may cause damage to the intraocular lens and potential complications during the implantation process.The instructions for use (ifu) instructs to use the company cartridge at operating room temperatures between 18° c (64° f) and 23° c (73° f).The instructions for use (ifu) instructs to use viscoelastic, which has been allowed to come to the operating room temperature.The lens model/diopters being used were not provided.It is unknown if qualified lenses were used.The instructions for use (ifu) instructs: the company intraocular lens delivery system is for implantation of qualified company foldable intraocular lens.No unqualified lenses should be used with the company intraocular lens delivery system.The company monarch¿ cartridges are qualified for use with compatible company company handpieces for the surgical implantation of company qualified foldable intraocular lens.Company foldable intraocular lens are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ophthalmic viscosurgical device (ovd)) combination.The use of an unqualified combination may cause damage to the intraocular lens and potential complications during the implantation process.The instructions for use (ifu) instructs to completely fill the cartridge with ophthalmic viscosurgical device (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ophthalmic viscosurgical device (ovd) in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ophthalmic viscosurgical device (ovd), which may result in damage.The instructions for use (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 ophthalmic viscosurgical device (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 instructions for use (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 half turn to engage the threads and then stop.The intraocular lens will now be in the dwell position.Inspect to ensure the plunger is behind the optic.The investigation has been completed based on current information.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaints are reviewed and monitored for adverse trends on a monthly basis.No adverse trends have been observed associated with the reported product and event.No further action has been identified for this reported event.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action is warranted at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH III IOL Delivery System, Cartridge D
• 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 ; +1(800)757-9780
• MDR Report Key: 50915649
• Report Number: 1119421-2026-01968
• Device Sequence Number: 14897605
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K063155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 8065977763
• Device Lot Number: 16254659
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2026
• 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
• Patient Sex: Unknown