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	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.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 nurse reported that during the intraocular lens (iol) implantation surgery, the preloaded lens had been scratched, and the initial procedure had been completed on the same day, no patient contact occurred.According to the additional information received, the lens was inserted in the normal way.Upon viewing the lens, a superficial scratch was noted across the center of the lens.The surgeon checked with the i/a handpiece to make sure it wasn't just loose viscoelastic, but it was indeed a scratched lens.It was then cut, removed, and a company lens of same model but half diopter more power was inserted without issue in an initial procedure.The surgeon stated that they were unsure what caused the issue, it could be either a defect when the lens was made or, more likely, as it was inserted, it rubbed against a component in the inserter.There was no patient harm.

• 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: 24799797
• Report Number: 9612169-2026-00776
• Device Sequence Number: 13148731
• Product Code: MJP
• UDI-Device Identifier: 00380658494278
• UDI-Public: (01)00380658494278(17)300212(11)250214(10)25988233
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: PXYAT3.205
• Device Lot Number: 25988233
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2025
• 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: CLAREON PANOPTIX PRO IOL / DELIVERY SYSTEM; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 77 YR
• Patient Sex: Female