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

Model Number	CNWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, the patient experienced waxy vision and was not accustomed to his/her vision and was dissatisfied.The iol was exchanged for monofocal iol 1 month 3 weeks 6 days following the initial implant procedure.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The lens was returned inside a clear plastic pouch.The lens was wrapped in folded white gauze material.Viscoelastic was dried on the lens.The lens was cut into pieces, typical of an insertion and removal from the eye.The lens was cleaned with klrp for further evaluation.The anterior optic was split extending from the line of cut damage through the optic center.The anterior optic surface and directly opposite on the posterior optic surface there are cracks in the outline of an instrument used to grasp the lens.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.It is unknown if qualified products were used.The root cause cannot be determined for the reported complaint.The lens was returned in pieces, typical of an insertion and removal from the eye.Additional lens damage was observed.Each lens was subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Information was provided that the multifocal non-toric company 21.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company monofocal lens.Due to the exchange of multifocal lens for a monofocal lens, this suggests that a monofocal lens may have been an improved choice for the patient's vision needs.File will be reopened if new information is received.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: 21639591
• Report Number: 1119421-2025-00748
• Device Sequence Number: 20966537
• Product Code: MFK
• UDI-Device Identifier: 00380652408158
• UDI-Public: (01)00380652408158(17)280224(11)240226(10)15811168
• 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: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.215
• Device Lot Number: 15811168
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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: CTR130A0 (HOYA); MONOFOCAL IOL-REPLACEMENT LENS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown