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	Material Discolored (1170)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Keratitis (1944); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that, after intraocular lens implantation surgery, the patient experienced ghosting in his intermediate vision since his cataract surgery.The surgeon's facility on post op 1 week checked his vision and with one lens he could see sharp and clear.So, he went to his optometrist who refracted him and said he has a residual astigmatic error of 1 diopter.The patient was seen by the surgeon again and reported having trouble seeing clearly at all distances, although they could still read down to an acuity of 20/15.The cornea was found to be extremely dry.This poor tear quality has resulted in keratitis sufficient enough to interfere with vision.The recommended treatment includes the use of artificial tears, warm compresses, and massaging of the meibomian glands until the next appointment.Additional information received and it states that after examining the patient's right eye, the doctor saw opacity which can be cleaned up with a laser.He mentioned that once he cleaned up the opacity with the laser, he would not be able to exchange the iol in his right eye.Options to reduce his residual astigmatism presented by the doctor was lri (limbal relaxing incisions) which he described as imprecise.He also mentioned removing the company lens from his right eye and replacing it with a monofocal toric iol (intraocular lens).Patient was using artificial tears and warm compress and omega-3 fish oil and b-complex vitamins but there was no change in his vision.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 was provided in b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating that, the astigmatism in right eye was at -0.5 diopter and the patient mentioned that he experienced dysphotopsia while driving at night.

• 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: 22749013
• Report Number: 9612169-2025-01595
• Device Sequence Number: 20991010
• Product Code: MJP
• UDI-Device Identifier: 00380658494612
• UDI-Public: (01)00380658494612(17)300310(11)250312(10)25993025
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: 25993025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/23/2025
• Date Device Manufactured: 03/12/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Male