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

Model Number	SY60WF
Medical Device Problem Codes	Break (1069); Optical Decentration (1360)
Health Effect - Clinical Codes	Corneal Edema (1791); Inflammation (1932)
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that, doctor implanted a lens and the patient has had a series of issues since her surgery which ended up removing a haptic.The haptic was amputated but it was unclear when.The lens was decentered on day 1 so there must have been some immediate defect not noted during surgery (surgery was uncomplicated).She later presented with delayed inflammation followed by corneal edema that was now known to be from a mobile/ floating haptic.Additional information has been requested but is not available at the time of this report.
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).

• 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: 50498510
• Report Number: 1119421-2026-01785
• Device Sequence Number: 13126412
• Product Code: HQL
• UDI-Device Identifier: 00380652251341
• UDI-Public: (01)00380652251341(17)290506(11)250508(10)16035458
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.130
• Device Lot Number: 16035458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 08/28/2026
• Date Device Manufactured: 05/08/2025
• 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; Other
• Patient Sex: Female