MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX PRO TRIFOCAL IOL W/AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	PXYAT0
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported during intraocular lens (iol) implant procedure, the surgeon noticed that the lens would not advance.Additional information was requested.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6., and h.11.The product was returned for analysis, and the reported complaint was observed.The device was returned in a blister tray inside the product carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The lens is present in the lens bay.The lever is moving freely, and the plunger is not advancing.The device is taken apart for further evaluation.The canister is fully punctured.Non-company lubricant is observed on the canister neck.No damage observed to o-rings.The device was reloaded and was reactivated with a new canister.The failure mode could not be replicated; the device activated with no issues.The root cause for the reported complaint is deemed to be manufacturing related (the faulty sub-assembly is supplied by company's vendor in bray).The product did not meet specifications.The plunger is not advancing when the lever is pressed.Based on the results from company product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX PRO TRIFOCAL 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: 23094620
• Report Number: 9612169-2025-01867
• Device Sequence Number: 8766202
• Product Code: HQL
• UDI-Device Identifier: 00380658493165
• UDI-Public: (01)00380658493165(17)300215(11)250217(10)25990821
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 12/12/2025

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: PXYAT0
• Device Catalogue Number: PXYAT0.140
• Device Lot Number: 25990821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 11/18/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/23/2025; 12/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown