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 Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	07/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following a cataract surgery with intraocular lens (iol) implantation, an elderly patient experienced toxic anterior segment syndrome (tass).The surgery was completed on the same day; however, details regarding how the procedure was completed were not provided.The patient's current condition was unknown.It was also stated that there were no plans to remove the lens at the time of the 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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 50191369
• Report Number: 1119421-2026-01663
• Device Sequence Number: 6053414
• Product Code: HQL
• UDI-Device Identifier: 00380652251372
• UDI-Public: (01)00380652251372(17)300331(11)260402(10)16227030
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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.145
• Device Lot Number: 16227030
• 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: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CUSTOM-PAK Surgical Procedure Pack.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown