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

Model Number	CCWTT3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	05/16/2025
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
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, patient experienced cloudiness and blurriness in the left eye once the iol was inserted, also started experiencing some issues with the right lens, including occasional blurriness while reading up close ¿ sometimes it is blurry and sometimes it is clear.Additional information was received indicating that the patient has been experiencing fluctuating vision in the left eye since undergoing cataract surgery on (b)(6) 2025.He reported intermittent cloudiness, difficulty reading fine print, and a sensation similar to having a grain of sand in the eye.The patient is currently using vasoconstrictor + antihistamine combination drops as prescribed by his surgeon.He also mentioned that he was able to read the serial numbers from the implant cards and observed that his vision improves when exposed to brighter light from the windows in his home.

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL UV ABSORBING 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: 22403688
• Report Number: 1119421-2025-01844
• Device Sequence Number: 8408111
• Product Code: MJP
• UDI-Device Identifier: 00380652457361
• UDI-Public: (01)00380652457361(17)281211(11)241213(10)15967423
• Combination Product (Y/N): N
• 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
• 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: CCWTT3
• Device Catalogue Number: CCWTT3.190
• Device Lot Number: 15967423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 07/04/2025
• Date Device Manufactured: 12/13/2024
• 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: CLAREON VIVITY TORIC EXT.UV ABS. IOL.; UNSPECIFIED NPAT DROPS.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male