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	Fibrosis (3167)
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that after an intraocular lens (iol) implant procedure, subsurface nano-glistenings with anterior iol opacification.In the surgeon's opinion product was cause or contribute to the event and in surgeon's prognosis most likely would not affect vision.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photos were returned.The photographs below demonstrate the following significant findings: this is an anterior segment photograph of an intraocular lens (iol) through a mid-dilated pupil.The lens has a mild opacification that appears to be through a majority of the lens that is illuminated from the slit beam.This appears to be subsurface nano glistening.This differs from glistening in the particle size is much smaller and it is the result a phase separation of water (from the aqueous humor) on the iol subsurface, whereas glistenings are attributed to water phase separation within the matrix of the hydrated iol material.It is rare for this to impact the quality or quantity of vision.The other two photographs included in this file are of poorer quality but appear to support this same conclusion.Based on our observation of the attached photos, this appears to be subsurface nano glistening.A definitive determination of the reported complaint cannot be made without the evaluation of the physical product.No sample was returned for analysis.Based on the results from the product history record, the products met release criteria.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: 24365395
• Report Number: 9612169-2026-00368
• Device Sequence Number: 12072187
• Product Code: HQL
• UDI-Device Identifier: 00380652393676
• UDI-Public: (01)00380652393676(17)261218(11)231220(10)25773929
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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 Model Number: CNA0T0
• Device Lot Number: 25773929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 12/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENDOCOAT AND HEALON.; OPERATIVE : EPI-SHUGARCAINE.; OPERATIVE: INTRACAMERAL MOXIFLOXACIN,; OPERATIVE: SUBCONJUNCTIVAL KENALOG.; PRE-OP PHENYLEPHRINE, CYCLOPENTALATE, TROPICAMIDE.; PRE-OPERATIVE: MOXIFLOXACIN, KETOROLAC,
• Patient Age: 86 YR
• Patient Sex: Male