MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. CLAREON PANOPTIX PRO Trifocal TORIC UV Absorbing IOL w/AutonoME Delivery System; Lens, Intraocular, Toric Optics

Model Number	PXCAT5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-health care professional reported that after the intraocular lens (iol) implantation surgery, the patient's vision was nearly always wavery, 4 months after initial implantation surgery, the patient was told that it may improve.It was very distracting and distressing for the patient.The patient's medium and distant vision was not clear or distinct.Even now with a new prescription for glasses, the patient could not read road signs.The patient could see blobs of color in the field, although the patient knew they are flowers, but couldn't identify them, until standing next to them.The patient could not read a menu posted on a board unless directly underneath it.However, the patient's vision is 20/20.The patient is now using new glasses, and eye drops several times a day.Additional information was received stating that the patient experienced halo/glare street lights & headlights had multiple rings, metal jewelry in the daylight glows with halos making it difficult to put on a bracelet, need sunglasses outside because the light was uncomfortably bright.The patient also experienced dry eye post-operatively.There are two medical device reports associated with this patient.This report is associated with the left eye.
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).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 TORIC UV Absorbing 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 ; +1(800)757-9780
• MDR Report Key: 50300296
• Report Number: 9612169-2026-01875
• Device Sequence Number: 18565518
• Product Code: MJP
• UDI-Device Identifier: 00380658492274
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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: PXCAT5
• Device Catalogue Number: PXCAT5.185
• Device Lot Number: 26151224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 11/17/2025
• 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 Sex: Unknown