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	PXCAT3
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported that during an intraocular lens (iol) implantation procedure, surgeon had an issue with two injectors on the same case.Both the devices were inoperable, so the surgeon manually loaded the second iol and completed the surgery.Additional information has been received and stated, the plunger was pushed past the lens during the lens insertion into the eye and in surgeon¿s opinion this contributed to or caused the event.The procedure was completed on the same day and the second lens still remains implanted.There was no harm or complication to the patient.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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 ; +1(800)757-9780
• MDR Report Key: 50894798
• Report Number: 9612169-2026-02185
• Device Sequence Number: 10762357
• Product Code: MJP
• UDI-Device Identifier: 00380658491482
• UDI-Public: (01)00380658491482(17)300817(11)250819(10)26088165
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: PXCAT3
• Device Catalogue Number: PXCAT3.280
• Device Lot Number: 26088165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 08/19/2025
• 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: Amvisc viscoelastic
• Patient Sex: Unknown