MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2026
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during the intraocular lens (iol) implant procedure, the iol found to be defective.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Additional information provided in b.5.And h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that, the surgeon implanted the lens and then requested the same lens after noting a defect in the original injected lens.The first lens was explanted and alternate was implanted into patient.The originally scheduled procedure completed the same day.There were no damages noted to the outer carton or packaging and no damage noted to the shipping container.
Additional Manufacturer Narrative
Additional information provided in d.10.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC 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 ; 8007579780
• MDR Report Key: 24544029
• Report Number: 1119421-2026-00496
• Device Sequence Number: 20256132
• Product Code: HQL
• UDI-Device Identifier: 00380652251440
• UDI-Public: (01)00380652251440(17)281116(11)241118(10)15950791
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2026

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: SY60WF
• Device Catalogue Number: SY60WF.180
• Device Lot Number: 15950791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 03/12/2026; 04/14/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/06/2026; 05/11/2026
• Date Device Manufactured: 11/18/2024
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Patient Age: 79 YR
• Patient Sex: Unknown