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

Model Number	PXYAT4
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
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 following intraocular lens (iol) implantation, the patient experienced blurry vision.Subsequently the lens was removed and replaced with an anterior chamber intraocular lens (atiol) in a secondary procedure.The clinical reason for explant was displacement of ocular lens.According to the additional information received, the surgeon attributed the event to the displacement of iol.The lens exchange was performed using a company lens of same model but half diopter more power in the patient¿s left eye.There was no further impact to the patient.
Additional Manufacturer Narrative
The product was returned for analysis.The reported complaint cannot be confirmed from the returned sample.Intraocular lens (iol) received in 3 segments inside sample container.The reporter stated that the company-provided 13.0 diopter iol was replaced with a company-provided 13.5 diopter iol.The root cause for the reported complaint could not be determined.The exchange from a company-provided 13.0 diopter iol to a company-provided 13.5 diopter iol, may suggest that the replacement lens was an improved choice for the patient's vision needs.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 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: 24617108
• Report Number: 9612169-2026-00599
• Device Sequence Number: 15846883
• Product Code: MJP
• UDI-Device Identifier: 00380658494612
• UDI-Public: (01)00380658494612(17)301001(11)251003(10)26121903
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PXYAT4
• Device Catalogue Number: PXYAT4.130
• Device Lot Number: 26121903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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: ORA SYSTEM WITH VERIFEYE MESSAGING.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown