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 Codes	Blurred Vision (2137); Visual Impairment (2138); Eye Irritation (4803)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 consumer reported that following an intraocular lens (iol) implant procedure, her vision clarity for close, mid and distance never improved past a weak 20/40 distance and visual acuity was not as expected.It was also stated that post operation she was experiencing hazy vision and also there was constant feeling of discomfort in outer mid to lower part of eyeball.In the second week pressure normal range, visual acuity still not improved at close, mid or distance.Feeling of discomfort in outer mid/lower part of eyeball remaining, very blurry 20/40 was noted at distance.Additional information has been requested, received and stated the surgeon believe the patient was just unable to tolerate the multifocal nature of the lens, contributing to her dissatisfaction at all distances.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated cartridge and handpiece information was not provided.A viscoelastic was indicated which would not be qualified for use with any lens or company cartridge combinations.The product investigation could not identify a root cause for the reported complaint.The product remained implanted.Each lens is 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.Information was provided that in the doctor's opinion; the surgery was a success despite the patient's subjective dissatisfaction.In the doctor's opinion, the patient was just unable to tolerate the multifocal nature of the lens, contributing to patient dissatisfaction at all distances.The file indicated an explant is planned.The file will be reopened if new information or the sample 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: 21985785
• Report Number: 1119421-2025-01326
• Device Sequence Number: 8312061
• Product Code: MFK
• UDI-Device Identifier: 00380652407960
• UDI-Public: (01)00380652407960(17)280513(11)240515(10)15855566
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: CNWTT0.120
• Device Lot Number: 15855566
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/20/2025
• Date Device Manufactured: 05/15/2024
• 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: AMVISC PLUS (OVD).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Sex: Female