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

Model Number	CCWTT0
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	06/01/2023
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 non-healthcare professional reported via united states of america health authority that following an intraocular lens (iol) implant procedure, the patient experienced glare, halos, shadows, positive and negative dysphotopsia, inability to see distant and hazy vision.Reporter was dissatisfied with design of iol.Additional information has been requested and received stating that started noticing symptoms on the day of the iol implant in the left eye.The patient made numerous visits to the surgeon and other optometrists and tried prescription glasses and over the counter glasses.The patient had a vitrectomy and a yag laser on the affected eye to try to make it tolerable.The patient experienced symptoms include extreme bright starbursts snowflakes on all lights, a hazy, foggy gauzy look to everything.The patient cannot drive due to glare off of other vehicles and no clear distance vision.In door lighting in stores, restaurants and offices was awful, patient just stay at home.Going anywhere at night where there are car lights or anything else lit up was not doable.Next step was to have the very risky surgery of exchanging the company lens for a mono focal iol.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed, and documentation indicated the product met release criteria.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.The reporter was the patient.The patient information brochure was provided.The file will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.2., b.5.And d.6.B.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
Additional information has been received from consumer via call stating that the iol was exchanged for another model different diopter from same company lens, 2 years 10 days following the initial implant procedure.

• Brand Name: CLAREON PANOPTIX TRIFOCAL UV ABSORBING 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: 21742983
• Report Number: 1119421-2025-00886
• Device Sequence Number: 4109361
• Product Code: MFK
• UDI-Device Identifier: 00380652413695
• UDI-Public: (01)00380652413695(17)241220(11)210729(10)15241346
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2025

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: 12/20/2024
• Device Model Number: CCWTT0
• Device Catalogue Number: CCWTT0.225
• Device Lot Number: 15241346
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 05/13/2025; 06/27/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 06/05/2025; 07/22/2025
• Date Device Manufactured: 07/29/2021
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female