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

Model Number	CC60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Blurred Vision (2137); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	02/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following a cataract surgery with an intraocular lens (iol) implant procedure, the patient was diagnosed with tass (toxic anterior segment syndrome).The exact timing and details of the surgery were initially unknown.The surgery was uneventful, and the patient¿s first postoperative visit showed no problems.Additional information was requested and received that the tass (toxic anterior segment syndrome) was observed two days after the surgery.At that time, the patient also experienced corneal edema and blurred vision.The patient was treated with topical medications.The current condition of the patient is unknown.There are two medical device reports associated with this report.This file is 2 of 2.
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 UV ABSORBING 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: 24923135
• Report Number: 1119421-2026-00815
• Device Sequence Number: 13086035
• Product Code: HQL
• UDI-Device Identifier: 00380652396929
• UDI-Public: (01)00380652396929(17)290930(11)251002(10)16120401
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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: CC60WF
• Device Lot Number: 16120401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 10/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BSS STERILE IRRIGATING SOLUTION.; CENTURION VISION SYSTEM.; CENTURION.; CUSTOM-PAK SURGICAL PROCEDURE.; INFINITI VISION SYSTEM.; KETORLAC.; MOXIFLOXACIN.; OPHTHALMIC MOXI.; PHACO TIP.; POVIDONE IODINE 5%.; PROPARACAINE.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.; TROPIPHEN.; VISCOAT OVD.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male