MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. CLAREON PANOPTIX PRO Trifocal UV Absorbing IOL w/AutonoME Delivery System; Intraocular Lens

Model Number	PXCAT0
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Visual Disturbances (2140); Posterior Capsule Opacification (4807)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient as could not tolerate halos and glare, could not adapt to lens, posterior capsule opacification and clinical reason for explant being -0.75 +1.00 x 5.Patient was not able to adapt the lens and posterior capsular opacification.In the surgeons opinion, some blur caused or contributed to the event.There was no further impact to the patient.The iol was explanted and exchanged for a different diopter and model lens following the initial implant procedure.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
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).

• Brand Name: CLAREON PANOPTIX PRO Trifocal UV Absorbing IOL w/AutonoME Delivery System
• Common Device Name: Intraocular Lens
• Manufacturer (Section D): Alcon Laboratories Ireland Ltd.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): Alcon Laboratories Ireland Ltd.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50218157
• Report Number: 9612169-2026-01833
• Device Sequence Number: 13325832
• Product Code: HQL
• UDI-Device Identifier: 00380658490423
• UDI-Public: (01)00380658490423(17)301110(11)251112(10)26151253
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: PXCAT0
• Device Catalogue Number: PXCAT0.240
• Device Lot Number: 26151253
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 11/12/2025
• 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 IOL, Cartridge B; MONARCH III IOL, Injector; PROVISC Ophthalmic ViscoSurgical Device
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female