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

Model Number	CCWTT5
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	05/15/2025
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's internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following intraocular lens implant procedure the patient had decreased vision, blurry vision and had multiple snowflake like deposits scattered throughout the intraocular lens.The patient underwent yag laser capsulotomy.Additional information has been requested.
Event or Problem Description
Additional information has been received and stated that the snowflakes dissipated after performing a yag laser on them.The iol was not explanted.
Additional Manufacturer Narrative
Additional information was provided in b.5., and h.11.The manufacturer internal reference number is: (b)(4).

• 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: 22230119
• Report Number: 1119421-2025-01687
• Device Sequence Number: 9098662
• Product Code: MJP
• UDI-Device Identifier: 00380652458474
• UDI-Public: (01)00380652458474(17)250328(11)211104(10)15301488
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2025
• Device Model Number: CCWTT5
• Device Catalogue Number: CCWTT5.215
• Device Lot Number: 15301488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/29/2025
• Date Device Manufactured: 11/04/2021
• 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: MONARCH II LOADING FORCEPS; MONARCH III IOL, CARTRIDGE C; MONARCH III IOL, INJECTOR; PROVISC OVD
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown