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); Halo (2227)
Type of Reportable Event	Serious Injury
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 non-health care professional reported that following an intraocular lens (iol) implant procedure, the patient was able to see distance one day later the surgery.After a week since surgery she cannot read or see near and experienced blurry vision.At night the halos around every light source are significant.About 4-5 rings around headlights and streetlights.It makes it difficult to read street signs.Additional information was received and stated, patient also experienced blurry vision at intermediate distance and severe starburst around light sources at night.At one week post-operative visit the eye looks healthy and seems to be healing with very little swelling and doctor suggested using dry eye moisturizing drops.
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 and stated, patient said she was 7 weeks from the surgery and still cannot clearly see and her doctor said that she had healed well.The distance vison was good but letters are blurry and cannot read street signs, the intermediate vision can make out the letters but blurry at close and cannot read any letters.In nighttime there was halos and starburst making it very difficult to drive.She was waiting for another month to see if the vision gets better and will not have surgery on her second eye.

• 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: 23803656
• Report Number: 9612169-2025-02515
• Device Sequence Number: 13108776
• Product Code: HQL
• UDI-Device Identifier: 00380658490263
• UDI-Public: (01)00380658490263(17)300405(11)250407(10)26007858
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/27/2026

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: PXCAT0.160
• Device Lot Number: 26007858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/27/2026
• Date Device Manufactured: 04/07/2025
• 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: 72 YR
• Patient Sex: Female