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

Model Number	PXYAT3
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A healthcare professional reported before intraocular lens (iol) implant procedure, the surgeon identified the lens as defective and did not proceed with implantation.The surgery was completed on the same day, and it was confirmed that there had been no patient contact or harm.The reporter also noted that the defective lens had been discarded.Additional information has been requested.
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 loose in a plastic bag.The lock-out assembly has been removed.No ophthalmic viscosurgical devices (ovd) is observed in the device.The plunger has been advanced to mid nozzle and is advanced over the iol.The iol is advanced into the nozzle entry and is damaged.Plunger override was observed.The root cause may be related to failure to follow the instructions for use (ifu).No viscoelastic was observed in the device.The ifu instructs: fill the device until ovd can be observed flowing to the nozzle tip.This will require approximately 0.28 ml of viscoelastic.If no viscoelastic is placed in the device this will cause no coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to override the lens.Based on the results from the 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: 23437814
• Report Number: 9612169-2025-02179
• Device Sequence Number: 17339072
• Product Code: MJP
• UDI-Device Identifier: 00380658494230
• UDI-Public: (01)00380658494230(17)300216(11)250218(10)25988222
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: PXYAT3
• Device Catalogue Number: PXYAT3.185
• Device Lot Number: 25988222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2025
• 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 OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 75 YR
• Patient Sex: Female