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

Model Number	PXCAT5
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 surgery they noticed that the autonome plunger had very rough edges.Lens was implanted without problems.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.Reported complaint was observed on the returned photo.Photo provided shows an activated autonome device.The plunger appears to be fully advanced outside the nozzle tip.There appears to be damage to the plunger tip.No iol visible in photo.Based on our observation of the attached photo there appears to be damage to the plunger tip.A definitive determination of the reported complaint cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.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 UV ABSORBING 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: 23728974
• Report Number: 9612169-2025-02446
• Device Sequence Number: 9687485
• Product Code: MJP
• UDI-Device Identifier: 00380658492236
• UDI-Public: (01)00380658492236(17)300302(11)250304(10)25988386
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 02/28/2026

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: PXCAT5
• Device Catalogue Number: PXCAT5.165
• Device Lot Number: 25988386
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/02/2026
• Date Device Manufactured: 03/04/2025
• 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
• Patient Sex: Unknown