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

Model Number	CCWTT0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Retinal Degeneration (2049); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The product investigation could not identify a root cause for the reported complaint.The product was not returned.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 the left eye (os) implanted (b)(6) 2025.Both post op visits went great with 20/20 vision.In (b)(6) 2025, the patient indicated that they lost up-close vision in their left eye.The root cause for the sudden onset of the visual issue 6 months after the initial implant could not be determined.The patient indicated they were scheduled to see a retina specialist.The surgeon provided a written note, which stated patient was no longer near sighted.No reason was given for the change in visual acuity.The reporter (patient) provided updated information.The retina specialist found a macular pucker, which caused the vision loss.The retina specialist indicated that 15 percent of older people can get this, and it could stay the same or get worse over time.The retina specialist discussed treatment: wait and see or surgery for the membrane.The reporter opted for surgery which was conducted on (b)(6) 2025.The reporter indicated their vision is much better, but not 20/20.The doctor said it can take up to a year to see all of the improvement.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implant procedure, in the month of june patient had an appointment with the optometrist because patient lost up close vision in left eye and it had become blurry to the point that patient cannot read or make out the letters.It was uncomfortable reading using only one eye.Additional information was received and stated, the optometrist referred patient to a retinal specialist.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated, patient lost near vision because he was no longer nearsighted.Additional information was received and stated, patient optometrist referred him to a retina specialist, who said he had a macular pucker, which caused the vision loss.He said 15 percent of older people can get this and it could stay the same or get worse over time.Also, eye trauma can cause this or laser treatment.Retinal specialist said treatment can be just wait and see if it gets worse or go for surgery to have the membrane that is building up over the retina and have him do a membrane peel.Retinal specialist said he probably will never get back to 20/20 but will come close.Patient opted for surgery on october 21, and his vision was much better but not 20/20.The doctor said it can take up to a year to see all of the improvement.

• Brand Name: CLAREON PANOPTIX TRIFOCAL UV ABSORBING INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL
• 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: 23051766
• Report Number: 1119421-2025-02474
• Device Sequence Number: 9824522
• Product Code: MFK
• UDI-Device Identifier: 00380652413558
• UDI-Public: (01)00380652413558(17)280601(11)240603(10)15869354
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/27/2025

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: CCWTT0
• Device Catalogue Number: CCWTT0.155
• Device Lot Number: 15869354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/27/2025
• Date Device Manufactured: 06/03/2024
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; ORA SYSTEM WITH VERIFEYE MESSAGING, CART; TOTALVISC OVD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Male