MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon Toric UV Absorbing IOL; Lens, Intraocular, Toric Optics

Model Number	CCW0T3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that reported that after cataract surgery with intraocular lens (iol) implant procedure patient experienced blurry vision and refractive surprise.The patient continued treatment with prescribed ophthalmic medications (eye drops) as directed.Additional information has been requested but is not available at the time of this report.There are two medical reports associated with this patient.This is for right 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 Laboratories Ireland Ltd.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): Alcon Laboratories Ireland Ltd.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50852086
• Report Number: 9612169-2026-02131
• Device Sequence Number: 18518569
• Product Code: MJP
• UDI-Device Identifier: 00380652432023
• UDI-Public: (01)00380652432023(17)260808(11)220810(10)25469678
• 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
• 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 Expiration Date: 08/08/2026
• Device Model Number: CCW0T3
• Device Catalogue Number: CCW0T3.295
• Device Lot Number: 25469678
• 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: 08/10/2022
• 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 drops; ORA System with VerifEye Messaging, Cart; Prednisolone Acetate eye drops; Vigamox (moxifloxacin) eye drops
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male