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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported experiencing large halos around headlights both during day and night following the implantation of an intraocular lens (iol).This distortion was causing unacceptable interference with safe driving, especially at night.Based on the additional information provided, the patient began experiencing symptoms immediately following cataract surgery.She discussed these concerns with the surgeon, who advised that the symptoms might improve after six months.The patient reported that her distance vision was not perfectly corrected, prompting her to consult an eye care specialist for a new prescription.The new glasses resulted in excellent distance vision, while halos around the lights were only slightly changed.There are two medical device reports associated with this patient.This report is associated with the right eye.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
Based on new information received 0n 04-feb-2026, the consumer can no longer drive at night.
Additional Manufacturer Narrative
Additional information provided in sections b.5., h.3., h.6., and h.11.The product was not returned for analysis.The root cause of the reported complaint could not be determined.According to the instructions for use (ifu), some visual effects may be expected due to the superposition of focused and unfocused multiple images.These may include some perception of halos, radial lines around point sources of light (starbursts) under night-time conditions, or glare, as well as other visual symptoms.As with other multifocal intraocular lenses (iols), these visual disturbances may be significant enough in some cases that the patient may request explantation of the lens.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 23630436
• Report Number: 9612169-2025-02336
• Device Sequence Number: 10291898
• Product Code: HQL
• UDI-Device Identifier: 00380658490324
• UDI-Public: (01)00380658490324(17)300517(11)250519(10)26038972
• 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
• 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): 02/12/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: PXCAT0
• Device Catalogue Number: PXCAT0.190
• Device Lot Number: 26038972
• 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: 01/20/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/12/2026
• Date Device Manufactured: 05/19/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female