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	Material Deformation (2976)
Health Effect - Clinical Codes	Eye Injury (1845); Hyphema (1911); Iritis (1940); Red Eye(s) (2038)
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 internal reference number is:(b)(4).
Event or Problem Description
A physician reported that during intraocular lens implantation surgery, the surgeon noticed that the patient had some floppiness to the iris and it was not dilated widely.Because of this surgeon could not insert the tip as far into the eye and so much pressure was needed to keep the tip from backing out, there was some chamber shallowing and the injection of the lens traumatized the iris, so the patient had an iris defect and hyphema.Scheduled procedure was completed the same day and the lens left implanted.In the surgeon¿s opinion, cartridge tip was too short and cannot be inserted far enough into the ac (anterior chamber) it caused or contributed to the event.In the surgeon¿s prognosis, the patient was seeing well, but have iris defect and it was permanent.
Additional Manufacturer Narrative
Corrected information provided in h.6.Correction: on initial mdr the event code should have been e0824 instead of e0833 and e0828 instead of e0819.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 ; 8007579780
• MDR Report Key: 22531606
• Report Number: 9612169-2025-01407
• Device Sequence Number: 15436971
• Product Code: HQL
• UDI-Device Identifier: 00380658490317
• UDI-Public: (01)00380658490317(17)300202(11)250204(10)25990800
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: PXCAT0
• Device Catalogue Number: PXCAT0.185
• Device Lot Number: 25990800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 02/04/2025
• 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: AMVISC PLUS.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female