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

Model Number	PXYAT0
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, the lens was implanted and subsequently explanted due to the presence of air bubbles within the acrylic.The surgeon had to cut the lens and replaced it with another unspecified lens.The procedure was traumatic to the patient's eye.The surgeon reported that one piece of the lens contained the bubbles.Additional information has been requested.
Additional Manufacturer Narrative
The product and a video were returned for analysis, and the reported complaint was observed.Device not received.Only preload device carton and tyvek lid received together with two segments of iol (intraocular lens) in two separate sample containers.Sample container marked: 1a lens w/internal defect: an approx.2/3 of the iol optic received.The iol optic is cracked/fractured and scratched/marked - rejectable.The reported complaint is observed in the center of the optic area.Sample container marked: 1b remaining lens: one loose haptic and approx.1/3 of optic with haptic received in this container.The iol optic is scratched/marked - rejectable.The returned video shows implanted iol.The reported complaint "lens had bubbles within the acrylic" can be observed on the returned video at the center of the optic area.The root cause is deemed to be manufacturing related.The product did not meet specifications.Cosmetic defect was observed on the iol optic.As part of this investigation, awareness was directed to the appropriate inspection personnel.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 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: 23555462
• Report Number: 9612169-2025-02279
• Device Sequence Number: 10081555
• Product Code: HQL
• UDI-Device Identifier: 00380658493103
• UDI-Public: (01)00380658493103(17)300208(11)250210(10)25992988
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 03/02/2026

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: PXYAT0
• Device Catalogue Number: PXYAT0.110
• Device Lot Number: 25992988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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: 59 YR
• Patient Sex: Female