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

Model Number	PXYAT4
Medical Device Problem Codes	Material Discolored (1170); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that, during intraocular lens (iol) implantation surgery, while the iol was being implanted by the surgeon the tech said he saw a plume of smoke above the eye.The surgeon did not see this nor did the anesthesiologist.The iol came out fine and there was no patient harm.Additional information was received stating that the issue was noticed upon insertion of the lens into the patient's eye.
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
Additional information was provided in d.9., h.3., h.6.And h.11.The product was not returned for analysis.The root cause for the reported complaint could not be determined as no sample or photo were returned for analysis.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Corrected information provided in h.6.Correction: on initial mdr the product code should have been a2201 instead of a0407.Additional information was provided in d.9., h.3., h.6.And h.11.The product was returned for analysis, and the reported complaint could not be confirmed.The device was received in a plastic bag.Solution is dried in the device.The lock-out assembly has been removed.The plunger has been fully advanced outside of the device.The iol was not returned.The lever is moving freely.No "smoke" observed when the lever is pressed.The device is taken apart for further evaluation.The canister is fully punctured.Krytox is observed on the canister neck.No damage observed to o-rings or any other parts.The device was reloaded and was reactivated with a new canister.The failure mode could not be replicated; the device activated with no issues.Complaints have been received describing that gas was heard during activation, which led to slower plunger movement/ plunger stopped in some cases.The root cause is deemed to be vendor related.The most likely root cause is partial gas leak passing the canister o-ring, which results in liquid co2 escaping outside of the device and while cooling produces a visible plume.No component or process has been identified as being root cause, likely root cause is the assembly process and particularly the final assembly.As per the instructions for use (ifu), the lens should be inspected at the pause location prior implantation.Based on the results from alcon product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX PRO TRIFOCAL TORIC IOL W/AUTONOME DELIVERY SYSTEM
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 22360474
• Report Number: 9612169-2025-01312
• Device Sequence Number: 8586775
• Product Code: MJP
• UDI-Device Identifier: 00380658494728
• UDI-Public: (01)00380658494728(17)300322(11)250324(10)25988276
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2026

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: PXYAT4
• Device Catalogue Number: PXYAT4.185
• Device Lot Number: 25988276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 02/26/2026
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 09/17/2025; 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• 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: PROVISC VISCOSURGICAL DEVICE.
• Patient Sex: Female