MAUDE Adverse Event Report: Alcon Research, LLC - Huntington Clareon Toric UV Absorbing IOL; Lens, Intraocular, Toric Optics

Model Number	CCW0T6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Blurred Vision (2137); Visual Impairment (2138)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that after cataract surgery with intraocular lens (iol) implantation, the patient experienced blurred vision, refractive surprise, corneal edema, anterior chamber inflammation, residual hyperopia/refractive error, and anisometropia.The patient continued treatment with prescribed ophthalmic medications (eye drops) as directed.Additional information has been requested and received stating that iol was explanted and exchanged with different model different diopter company lens.There are two medical reports associated with this patient.This is for left eye.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: Clareon Toric UV Absorbing IOL
• Common Device Name: Lens, Intraocular, Toric Optics
• 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: 50852082
• Report Number: 1119421-2026-01921
• Device Sequence Number: 18518566
• Product Code: MJP
• UDI-Device Identifier: 00380652435161
• UDI-Public: (01)00380652435161(17)270326(11)230328(10)15599813
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: CCW0T6
• Device Catalogue Number: CCW0T6.275
• Device Lot Number: 15599813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 03/28/2023
• 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: Bromday (bromfenac) eye drop; Clareon Toric UV Absorbing IOL; ORA System with VerifEye Messaging, Cart; Prednisolone Acetate eye drop; Vigamox (moxifloxacin) eye drop
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male