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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A 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 non-healthcare professional reported that during the intraocular lens (iol) implant procedure they found that kinked/twisted rear haptic when the surgeon went to implant.There was no impact to the patient.Additional information has been requested however no further information available.
Event or Problem Description
Additional information received and stated that, the iol was incorporated into plunger tip with trailing haptic.This incident happened during iol delivery.In the surgeon¿s opinion injector caused the issue.The tip of the preload device did not contact with the patient and the surgeon could see the deformed iol in the cartridge tip.The surgeon prognosis was good.
Additional Manufacturer Narrative
Additional information provided a.1., a.2., a.3.A., b.3., b.5., d.5.And d.10.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo was returned.Reported complaint was observed on the returned photo.Received photo shows an activated company device on a monitor screen.The plunger is outside of the nozzle tip, but the plunger is not fully advanced.The majority of the intraocular lens (iol) is outside of the nozzle tip, one haptic appears intact, the optic is damaged.Although difficult to determine form the returned photo, part of one of the haptics appears to be caught/adhered to the plunger tip/nozzle tip, this haptic is damaged/bent/kinked.We are unable to determine the root cause for the reported complaint "kinked/twisted rear haptic".The product was not returned for analysis.Based on our observation of the attached photo, the plunger is not fully advanced.If the plunger is not fully advanced the trailing haptic may not release properly from the device.A final root cause cannot be determined based on available information and without the evaluation of the physical product.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: 22121972
• Report Number: 9612169-2025-01161
• Device Sequence Number: 6951298
• Product Code: MJP
• UDI-Device Identifier: 00380658491413
• UDI-Public: (01)00380658491413(17)300216(11)250218(10)25984993
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2025

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: PXCAT3.245
• Device Lot Number: 25984993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 08/07/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/28/2025; 08/29/2025
• 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: DUOVISC VISCOELASTIC SYSTEM
• Patient Age: 80 YR
• Patient Sex: Female