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	Vitreous Floaters (1866); Retinal Tear (2050); Blurred Vision (2137); Visual Disturbances (2140)
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 consumer reported that after an intraocular lens (iol) implantation procedure, had experienced a significant loss of long-distance and middle-distance vision, although they retained the ability to read up close.The vision remained unclear, with persistent haziness and cloudiness.The consumer also reported about consistent floaters and surprising flashes in the corners of both eyes.The consumer had underwent surgery for a retinal tear and vitreous hemorrhage a six weeks after intraocular lens (iol) implantation procedure and also underwent yttrium aluminum garnet (yag) laser surgery was performed.Even after 14 months after procedure, the issues were persistent at the time of reporting.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
Additional information was added in a.2., b.6., b.7., and d.10.The manufacturer internal reference number is:(b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaints the lens remains implanted.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was received from the implant faculty.No issues were reported at the time of the implant.The patient¿s visual acuity was reported as ucva 20/20 after the lens implant.The reporter was the patient.The lens was implanted (b)(6) 2023.The patient issues started (b)(6) 2023.The patient indicated the had a retinal tear, which was operated on (b)(6) 2023.They also had a vitrectomy six months after the implant.Patient was encouraged to speak with their surgeon regarding the continuing issues since the retinal tear occurred.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction information added in d.4.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that, it had been over two years since my multiple surgeries.None of the items had improved.Both eyes continue to have floaters on a consistent basis.Both eyes remain cloudy at all the times, regardless of time of day or conditions.
Additional Manufacturer Narrative
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: 19631982
• Report Number: 1119421-2024-01228
• Device Sequence Number: 8673792
• Product Code: MFK
• UDI-Device Identifier: 00380652408127
• UDI-Public: (01)00380652408127(17)250130(11)210908(10)15265556(21)15265556010
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/05/2025

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 Expiration Date: 01/30/2025
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.200
• Device Lot Number: 15265556
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/10/2024; 08/07/2024; 09/05/2024; 05/13/2025
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/06/2024; 09/05/2024; 10/05/2024; 06/06/2025
• Date Device Manufactured: 09/08/2021
• 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: BARRETT CALCULATOR.; DUOVISC VISCOELASTIC SYSTEM.; MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Unknown