MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CNA0T0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non healthcare professional reported that, the patient underwent surgery to replace the lens in both eyes.Immediately after the operation, the patient experienced an unexpected effect appeared on one eye all kinds of glare.These are diagonal glare from lamps, from reflected light in a mirror, from the reflection of sunlight from shiny surfaces.This was usually a color spectrum.Sometimes it's just white light from the lamps.At night, on the street, where there was little lighting, just saw diagonals of light and it was striped, apparently, it depends on the tilt of the headlights.Even sunlight can be reflected.When it was more illuminated, the patient saw everything, but with multiple rays of light.Patient went to the clinic on the third day after the operation and then a month later, but the surgeon said it was the patient individual perception.However, another doctor at the polyclinic, even before the patient had time to tell something, was surprised at the examination about sparkle of lens especially the left eye.The second eye also sometimes gave this effect, but less often and more smoothed out and there was no diagonal stripes.There was no life or health threat, death or loss of 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).

• Brand Name: CLAREON IOL WITH THE 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: 22665333
• Report Number: 9612169-2025-01506
• Device Sequence Number: 15325053
• Product Code: HQL
• UDI-Device Identifier: 00380652393584
• UDI-Public: (01)00380652393584(17)250711(11)220713(10)25442039
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/11/2025
• Device Model Number: CNA0T0
• Device Lot Number: 25442039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/30/2025
• Date Device Manufactured: 07/13/2022
• 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: 58 YR
• Patient Sex: Unknown