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

Model Number	CNWTT5
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the lens which was implanted in right eye was more opaque and patient had difficulty to see near.Patient stated she was in contact with the physician and he was investigating the occurrence of deposits on the iol and believed that they are not related to the lens or the material, but to the patients pre-existing condition.Additional information has been requested.
Additional Manufacturer Narrative
Correction information was provided in h.6.On initial medical device report (mdr) the fda product problem codes of b17 was submitted.It should have been b20.Additional information has been provided in h.3., h.6., and h.11.The product was not returned.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Associated products were not provided.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.The reporter was the patient.The issue was indicated to be bilateral.The physician was investigating the occurrence of deposits on the iols (intraocular lens) and believes that they are not related to the lens or the material, but to the patient's pre-existing condition.The patient had prior corneal transplants due to fuchs¿ dystrophy.Information was provided that the patient will return for an appointment in august 2025.The manufacturer internal reference number is:(b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 22393327
• Report Number: 1119421-2025-01808
• Device Sequence Number: 9024462
• Product Code: MJP
• UDI-Device Identifier: 00380652469661
• UDI-Public: (01)00380652469661(17)280310(11)240312(10)15821967
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: CNWTT5
• Device Catalogue Number: CNWTT5.235
• Device Lot Number: 15821967
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/14/2025
• Date Device Manufactured: 03/12/2024
• 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
• Patient Age: 58 YR
• Patient Sex: Female