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

Model Number	CNWTT4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
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
Physician reported that following an intraocular lens (iol) implant procedure, the patient was unable to drive at night.Clinical reason for the explant is halos.The physician planned explant with advanced technology intraocular lenses (atiol).Additional information has been requested.
Event or Problem Description
Additional information has been requested and stated the iol was explanted and exchanged without any difficulty.
Additional Manufacturer Narrative
Additional information was added in b.2., b.5., d.5., d.6b., h.3., h.6.And h.11.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information was not provided.The product investigation could not identify a root cause for the reported complaint.Information indicated the clinical reason for the explant was due to halos.The company lens (2.25 cyl.) 19.5 diopter (add power +2.2/+3.2 diopter) was removed and replaced.The replacement lens information was not provided.The file follow up indicated that the exchange was scheduled for (b)(6) 2025.The follow up response from the doctor was confirmation that an intraocular lens (iol) exchange was performed without difficulty and the requested information was going to be provided.No additional information has not been received regarding the replacement lens information to date.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was added in a.2., a.3.A., b.5., b.6., d.10.
Event or Problem Description
Additional information has been requested and stated the iol was explanted and exchanged without any difficulty.Additional information has been received and stated the lens was replaced with another model same diopter company lens.There was no patient harm.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 21678644
• Report Number: 1119421-2025-00802
• Device Sequence Number: 18065638
• Product Code: MJP
• UDI-Device Identifier: 00380652469050
• UDI-Public: (01)00380652469050(17)270308(11)230310(10)15594446
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2025

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: CNWTT4
• Device Catalogue Number: CNWTT4.195
• Device Lot Number: 15594446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 06/05/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 06/05/2025; 07/04/2025
• Date Device Manufactured: 03/10/2023
• 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: DISCOVISC OVD.; MONARCH III IOL CARTRIDGE D.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Male