MAUDE Adverse Event Report: Alcon Research, LLC - Huntington Clareon Aspheric UV Absorbing IOL; Intraocular Lens

Model Number	CC60WF
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that, following the intraocular lens (iol) implantation procedure, a lens exchange was performed.The initially implanted lens was removed and replaced with a different type of lens.No further information was provided.
Additional Manufacturer Narrative
A sample product was not received for evaluation.A batch record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the medical device file were met.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

• Brand Name: Clareon Aspheric UV Absorbing IOL
• Common Device Name: Intraocular Lens
• Manufacturer (Section D): Alcon Research, LLC - Huntington; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): Alcon Research, LLC - Huntington; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50176683
• Report Number: 1119421-2026-01655
• Device Sequence Number: 15514714
• Product Code: HQL
• UDI-Device Identifier: 00380652396776
• UDI-Public: (01)00380652396776(17)300518(11)260520(10)16255112
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/07/2026

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 Model Number: CC60WF
• Device Lot Number: 16255112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 05/20/2026
• 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: Required Intervention
• Patient Sex: Unknown