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 Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
These four photos show an eye with a brown iris, a nondilated pupil, and a posterior chamber intraocular lens (iol) under moderately broad slit-lamp illumination.The top images appear to be the same photograph, while the bottom photos also seem to be identical to each other.In the top photos, direct illumination reveals multiple, discrete, minute opacities on or just beneath the anterior surface of the iol.While these opacities are visible within the pupil, assessing their extent beyond it is challenging due to the dark iris background and reduced visibility outside the illuminated area.The same opacities are also visible in the bottom images under retro illumination.The exact location of these findings - whether on or immediately behind the anterior iol surface - cannot be definitively determined from these two-dimensional images.Additionally, further assessment beyond this review is needed to accurately identify these findings.The manufacturer internal reference number is:(b)(4).
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).
Event or Problem Description
A healthcare professional reported that following an intraocular lens (iol) implant procedure, in postoperative follow-up visit surgeon observed opacification of the iol of the right eye.Additional information has been requested.

• 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: 20552451
• Report Number: 9612169-2024-01090
• Device Sequence Number: 3103064
• Product Code: HQL
• UDI-Device Identifier: 00380652396486
• UDI-Public: (01)00380652396486(17)261016(11)231018(10)25741670
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: 25741670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 01/06/2025
• Date Device Manufactured: 10/18/2023
• 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: HEALON PRO LOT: UP31121
• Patient Age: 82 YR
• Patient Sex: Unknown