MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, iol was slightly out of the way from the implantable cartridge, after the iol was inserted into the cartridge and implanted into the eye adhesion of iol haptic was resolved by the ia (irrigation/aspiration) tip.Additional information was requested.
Additional Manufacturer Narrative
The product was not returned.A video was provided.The cataract removal was shown.The initial view was limited in size, which appeared to be due to a circular aperture.Only a circular area in the center was viewable.The rest of the screen was dark.A company cartridge loading area was brought into view.The rest of the cartridge was out of the frame.Viscoelastic was added to the cartridge.The amount could not be determined due to the restricted view, but it appeared an adequate amount was used based on the time that elapsed.The view was opened up fully and the lens case was bought back into view.The lens was immersed in a brown liquid.This is not part of the ifu instructions for use).The lens was picked up with loading forceps.The lens was inserted into the loading area.The lens was not biased down.The trailing haptic was folded in on the optic surface and the lens was slightly advanced.The forceps were then removed and only one arm of the forceps was used to advance the lens farther in the cartridge.The cartridge came back into view.The lens was visible just past the nozzle entry area.The cartridge tip was inserted into the incision.The lens was advanced from the nozzle into the eye.As the lens was advanced, there appear to be a slight plunger override of the optic.The trailing haptic was slightly unfolded on top of the plunger.The lens was delivered without any other issues.The plunger was used to unfold the lens.The trailing haptic was slow to unfold, but fully unfolded during the i/a(irrigation/aspiration).The video ended with the lens still in the eye.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 cartridge and handpiece were indicated with a non-qualified viscoelastic.The root cause for the reported haptic issue may be related to a failure to follow the ifu.Review of the provided video indicated loading techniques that are not part of the ifu.The lens was immersed in a brown liquid.The lens was not biased down when it was loaded.The loading forceps were not being used properly to fully advance the lens and maintain the trailing haptic position.The loading forceps are specifically designed with the notch at the bottom to advance the optic to the necessary position while maintaining the trailing haptic position.As the lens had been immersed in liquid before loading, this may have also contributed to the trailing haptic unfolding.In addition, a non-qualified viscoelastic was indicated.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: 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.The manufacturer internal reference number is:(b)(4).

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 23790824
• Report Number: 1119421-2025-03132
• Device Sequence Number: 13379772
• Product Code: HQL
• UDI-Device Identifier: 00380652251464
• UDI-Public: (01)00380652251464(17)280408(11)240410(10)15837977
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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 Model Number: SY60WF
• Device Catalogue Number: SY60WF.190
• Device Lot Number: 15837977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/12/2025
• Date Device Manufactured: 04/10/2024
• 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: HEALON V; MONARCH III, CARTRIDGE D; MONARCH IOL, INJECTOR, UNSPECIFIED
• Patient Sex: Unknown