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	PXCAT4
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non health care professional reported that during an intraocular lens (iol) implant procedure, lens was advancing despite trying to stop it prior to lens implantation.Additional information was requested and received, stating that upon attempting to insert the lens through the incision, it was determined that the lens had advanced too far to remain stable and became completely exposed from the delivery system, getting stuck at the tip.During preparation, the lens continued to advance despite the scrub technician's attempts to stop it.The tip of the injector, with the exposed lens, touched the eye but did not enter the capsular bag.Surgery was completed by using back up lens without any harm 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).

• 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: 50774807
• Report Number: 9612169-2026-02075
• Device Sequence Number: 18747492
• Product Code: MJP
• UDI-Device Identifier: 00380658491857
• UDI-Public: (01)00380658491857(17)300924(11)250926(10)26110741
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: PXCAT4
• Device Catalogue Number: PXCAT4.220
• Device Lot Number: 26110741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 09/26/2025
• 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: B and L StableVisc.
• Patient Age: 75 YR
• Patient Sex: Female