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 Codes	Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2026
Type of Reportable Event	Malfunction

• 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: 50097875
• Report Number: 9612169-2026-01747
• Device Sequence Number: 10368705
• Product Code: HQL
• UDI-Device Identifier: 00380658490232
• UDI-Public: (01)00380658490232(17)300215(11)250217(10)25990783
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PXCAT0
• Device Catalogue Number: PXCAT0.145
• Device Lot Number: 25990783
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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
• Patient Age: 62 YR
• Patient Sex: Female