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

Model Number	SY60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Inflammation (1932); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported following an intraocular lens (iol) implant procedure, reported intermittent inflammation and glare in the right eye following cataract surgery on 25-jul-2024.He has a history of dry eye and foreign body sensation prior to surgery, which worsened postoperatively.He is currently using a topical immunomodulator/calcineurin inhibitor twice daily and a topical corticosteroid four times daily as needed for inflammation and dry eye; the last use of the corticosteroid was on (b)(6) 2026.He also uses over-the-counter lubricating/artificial tears throughout the day.His symptoms have slightly improved, but he wanted to have the lens evaluated to ¿cross it off the list.¿.
Additional Manufacturer Narrative
A sample device 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).

• 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: 24672611
• Report Number: 1119421-2026-00592
• Device Sequence Number: 10285510
• Product Code: HQL
• UDI-Device Identifier: 00380652251488
• UDI-Public: (01)00380652251488(17)271231(11)240102(10)15775499
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: SY60WF
• Device Catalogue Number: SY60WF.200
• Device Lot Number: 15775499
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 01/02/2024
• 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: CYCLOSPORIN DROPS BID; LOTEPREDNOL DROPS PRN; REFRESH AT PRN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male