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	Intraocular Pressure Increased (1937); Blurred Vision (2137)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that after the intraocular lens (iol) implant procedure, the patient had experienced very blurry vision.The blurriness persisted for about three weeks until her eye pressure returned to 14.The consumer believed that, due to the misshapen cornea, the 17.5-diopter lens was the wrong strength.The patient required 3.75-diopter reading glasses, 2-diopter glasses for computer use, and 1-diopter glasses for driving.The patient had a good outcome after surgery, however was due for a (yttrium aluminum garnet) yag laser capsulotomy in order to optimize the lens outcome which was ordered by the surgeon in (b)(6) 2024 at a postoperative visit the patient had scheduled the yag procedure for (b)(6) 2024 but then canceled it.Additional information has been requested however no further information available.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.A product was not returned for analysis.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).
Additional Manufacturer Narrative
On initial mdr the imdrf health code of f19 was incorrect.It should have been f26 on the original mdr.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: 22577922
• Report Number: 1119421-2025-02025
• Device Sequence Number: 21278334
• Product Code: MJP
• UDI-Device Identifier: 00380652457330
• UDI-Public: (01)00380652457330(17)260918(11)220920(10)15491826
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2025

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: 09/18/2026
• Device Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.175
• Device Lot Number: 15491826
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/22/2025
• Date Device Manufactured: 09/20/2022
• 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 IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Female