MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX PRO TRIFOCAL UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	PXCAT0
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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 nurse reported that during the intraocular lens (iol) implantation surgery, the leading haptic looked weird.
Additional Manufacturer Narrative
Corrected information provided in a.1., a.2., a.3.A., b.5.And d.10.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating that, the surgery was completed using back up lens without any harm to the patient.
Additional Manufacturer Narrative
The product was returned for analysis and damage to the haptic was observed.Intra ocular lens (iol) was returned outside of the device.The device was received in a blister tray inside the product carton.The lock-out assembly has been removed.Viscoelastic is observed in the device.The plunger has been advanced to the depth guard.No damage observed.The lens was returned outside of the device.Solution is dried on the iol.One haptic is bent/deformed.The product investigation could not identify the root cause for the reported complaint "leading haptic looked weird" as the lens was returned outside of the device.Due to this, we are unable to confirm the lens and the plunger position for advancement and determine a root cause.Damage to 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 (> 23 degree c / 73 degree f) 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 these investigation findings, we are unable to verify if the iol/device 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 UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• 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: 24092813
• Report Number: 9612169-2026-00141
• Device Sequence Number: 13321795
• Product Code: HQL
• UDI-Device Identifier: 00380658490331
• UDI-Public: (01)00380658490331(17)300126(11)250128(10)25990806
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 04/20/2026

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: PXCAT0
• Device Catalogue Number: PXCAT0.195
• Device Lot Number: 25990806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 01/27/2026; 03/27/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 02/19/2026; 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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