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 Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2026
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 nurse reported during intraocular lens (iol) implant procedure, the intraocular lens was damaged once inserted.The lens was explanted during initial procedure.The procedure was completed on same day using back iol.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided ind.9., h.3., h.6.And h.11.The product was returned for analysis, and the reported complaint was observed.The device was received loose in the product carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger has been fully advanced outside the nozzle.Broken haptic is observed between the plunger and the nozzle wall.The lens was returned outside of the device in a specimen container.Solution is dried on the intraocular lens (iol).One haptic is broken/torn and is present in the device.The root cause for the broken haptic could not be determined.Broken haptic is observed between the plunger and the nozzle wall.The plunger position in relation to the broken haptic during advancement cannot be determined.Due to this, we are unable to confirm the lens and the plunger position for advancement and determine a root cause.Broken haptics may occur: due to the use of a non-qualified viscoelastic.Material properties of non-qualified ophthalmic viscosurgical device (ovd)s may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause delivery issues and /or damage.If the operating room temperature is too high (greater than 23 degrees celsius or 73 degrees fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.In addition, haptic strength (modulus) decreases as the temperature increases and is more likely to break under stress.Any of the above listed causes alone, or in combination, may create the reported event.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: 24546767
• Report Number: 9612169-2026-00536
• Device Sequence Number: 5725349
• Product Code: MJP
• UDI-Device Identifier: 00380658491376
• UDI-Public: (01)00380658491376(17)301019(11)251021(10)26142369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/02/2026

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: PXCAT3.225
• Device Lot Number: 26142369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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: UNSPECIFIED OVD.
• Patient Age: 76 YR
• Patient Sex: Female