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

Model Number	CCA0T0
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
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 non-healthcare professional reported with a description of the doctor using the autonome lens noticed 3 intraocular lens (iol) distortions lines across the iol.This lens was implanted.Additional information has been received an observation of the surgeon as he was switching over to autonome.He was noticing distortion or reflection across lens as he was in irrigation and aspiration.The surgeon said he did not notice this before starting to use autonome.The lenses remained implanted.No patient impact.No visual issues.Only noticed as lens was being placed in eye.This report is associated with multiple complaints.This file is 1 of 3.
Additional Manufacturer Narrative
Additional information was added in e.1.And h.11.The product was not returned for analysis.Only photo and video were returned.Provided photo shows an implanted intraocular lens (iol) on a monitor screen.There are some light reflections visible over the iol optic.Due to the quality of the photo, the reported complaint could not be confirmed.Returned video shows an implanted iol on a monitor screen.The iol is manipulated with a surgical tool to show a cloudy/scratched appearance on the iol.The origin of the reported complaint cannot be confirmed.Complaints have been received reporting a potential presence of 'polychromatic sheen'.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 ASPHERIC UV ABSORBING IOL WITH 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: 20685303
• Report Number: 9612169-2024-01173
• Device Sequence Number: 7229971
• Product Code: HQL
• UDI-Device Identifier: 00380652397285
• UDI-Public: (01)00380652397285(17)271130(11)231202(10)25758919
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: CCA0T0
• Device Lot Number: 25758919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 03/11/2025
• Date Device Manufactured: 12/02/2023
• 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