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 Codes	Device Difficult to Setup or Prepare (1487); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during surgery, was inserting the lens, the trailing haptic was stuck on the injector.They revised the tip of the injector and noticed that it was bent and defective.No harm to patient and case still went well.Additional information has been requested and received stating that the procedure completed on the same day with new lens.The surgeon prognosis stated that patient was fine.
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).
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The product was not returned for analysis.Only photo was returned.Damage to the plunger tip was observed on the returned photo.Photo provided shows what appears to be an autonome nozzle.The plunger is advanced outside the nozzle tip.There appears to be damage to the plunger tip.We are unable to determine the root cause for the reported complaint "trailing haptic was stuck on inj, tip of inj noted to be bent & def".The product was not returned for analysis.Trailing haptic may become stuck: if the lens has become misaligned in the lens bay during the manufacturing process.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds 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 the lens to advance incorrectly.If the operating room temperature is too high (> 23 degree c / 73 degree f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.Any of the above listed causes alone, or in combination, may create the reported event.Based on our observation of the attached photo, there is damage to the plunger tip.As the product was not returned for analysis, definitive determination of the reported complaint cannot be made.In addition to this, all plungers are 100% inspected as per approved manufacturing procedures at the vendor site and the observed plunger damage would not meet the release criteria.Based on this investigation findings, we are unable to verify if the product contributed to the 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: 23632354
• Report Number: 9612169-2025-02343
• Device Sequence Number: 18715097
• Product Code: MJP
• UDI-Device Identifier: 00380658491383
• UDI-Public: (01)00380658491383(17)300712(11)250714(10)26068720
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: PXCAT3.230
• Device Lot Number: 26068720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/16/2026
• Date Device Manufactured: 07/14/2025
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 54 YR
• Patient Sex: Male