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

Model Number	SY60WF
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported after intraocular lens (iol) implant procedure, the lens is white and cloudy.Additional information was requested and received stating that no subjective symptoms were associated with this finding.No plan for replacing iol.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.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 ; +1(800)757-9780
• MDR Report Key: 50948919
• Report Number: 1119421-2026-01979
• Device Sequence Number: 10429641
• Product Code: HQL
• UDI-Device Identifier: 00380652251594
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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.255
• Device Lot Number: 15899511
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 08/07/2024
• 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: MONARCH III IOL Cartridge D; MONARCH III IOL Injector; Opegan-Hi
• Patient Sex: Unknown