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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implantation procedure, the patient had experienced blurred vision, halos and unhappy with vision.The lens was rotated and repositioned by the surgeon approximately three months after the surgery.Additional information has been requested but is not available at the time of this report.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
The 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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 ; +1(800)757-9780
• MDR Report Key: 50174271
• Report Number: 1119421-2026-01649
• Device Sequence Number: 8270424
• Product Code: MJP
• UDI-Device Identifier: 00380652457378
• UDI-Public: (01)00380652457378(17)280814(11)240816(10)15902226
• 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): 08/07/2026

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 Model Number: CCWTT3
• Device Catalogue Number: CCWTT3.195
• Device Lot Number: 15902226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 08/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female