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

Model Number	CNA0T0
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
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.Provided photos show an implanted iol in an eye.Polychromatic sheen can be observed on the lens.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following the intraocular lens (iol) implant procedure, the surgeon noticed a glistening in the iol.Additional information received and stated that there was no impact to the patient.There are two medical device reports associated with this patient.This report is associated with the right eye.
Additional Manufacturer Narrative
Corrected information provided in b.5.Additional information provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photos were returned and polychromatic sheen can be observed on the lens.A product history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Provided photos show an implanted iol in an eye.Polychromatic sheen can be observed on the lens.The root cause is most likely manufacturing related.Complaints have been received describing that lenses were reported by doctors for the presence of a ¿polychromatic sheen¿ visible.This observation has been reported clinically and confirmed in laboratory settings to disappear over time following implantation and is often no longer visible by one day following surgery.However, in some cases, this observation may be apparent for longer before disappearing.The appearance is a result of a temporary change in the surface of the iol that occurs during the delivery process and is not associated with any foreign material or contamination.This is only visible under certain orientations and illumination settings and begins to resolve over time once the iol is delivered.The cause of the appearance is a result of a change in the positioning of the iol that was implemented in the manufacturing process and has since been addressed in production.There are no adverse impacts or lasting effects on the iol or the patient.Based on the results of the product investigation and testing, it was confirmed that there are no adverse events or clinical impact on vision associated with this finding.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
This report involves three patients.This medical device report specifically pertains to the right eye of the 2nd patient.

• 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: 25083434
• Report Number: 9612169-2026-01051
• Device Sequence Number: 10565432
• Product Code: HQL
• UDI-Device Identifier: 00380652393683
• UDI-Public: (01)00380652393683(17)260624(11)230626(10)25667668
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/24/2026
• Device Model Number: CNA0T0
• Device Lot Number: 25667668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/23/2026
• Date Device Manufactured: 06/26/2023
• 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
• Patient Sex: Unknown