MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Vitreous Loss (2142); Diplopia/Double Vision (4802)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the lens was dislocated and progressively moved nasally.The patient experienced blurred vision and saw rings to the lateral aspect of his vision.It appeared that the capsule was fibrosing, though his pupil did not dilate enough to allow visualization on that day.The patient returned to the operating room, where a non-company pupil expansion ring was used to hold the iris open, inflate the capsule, and rotate the implant to ensure stability and centration.The patient had previously undergone phacoemulsification and an intraocular lens procedure but was dissatisfied with the quality of visual acuity at both distance and near in the affected eye.He was straining to see and was unable to drive, watch tv, or read.He had monocular diplopia.During the lens repositioning procedure, complications occurred including vitreous loss, and an anterior vitrectomy was performed.The temporal haptic of the intraocular lens was grasped, and scissors were used to cut the lens implant optic in half.Each half was dialed out of the wound.A company posterior chamber lens implant was then injected into the eye and placed into the ciliary sulcus without complication.The lens was exchanged for another model with the same diopter and same company 2 months and 25 days following the initial procedure.Clinical reason for explant was mentioned as dislocated lens.
Additional Manufacturer Narrative
Additional information was provided in h.3.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.Associated products were not provided.It is unknown if qualified products were used.However, this is not applicable to the reported event.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100 percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the multifocal company 21.5 diopter, add power +2.2 and 3.2 lens was replaced with a monofocal company 21.5 diopter lens.Due to the exchange of a multifocal lens to a monofocal lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.No additional information has been provided at this time.The manufacturer internal reference number is:(b)(4).

• Brand Name: CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 23728875
• Report Number: 1119421-2025-03090
• Device Sequence Number: 10631891
• Product Code: MFK
• UDI-Device Identifier: 00380652408158
• UDI-Public: (01)00380652408158(17)280828(11)240830(10)15913480
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.215
• Device Lot Number: 15913480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 08/30/2024
• 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: IOL SCISSORS; MALUGIN RING
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Male