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

Model Number	CNW0T5
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon reported that after an intraocular lens (iol) implant procedure, surgeon noticed a film of haze on the surface of the iol during post operative day 1.Additional information was requested and received stating the lens was not explanted and still retained in eye.Additional information was requested and received stating the surgeon confirmed that patient vision worsens and has scheduled for an explant.Additional information was requested and received stating the lens was explanted and replaced with same model company lens.
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).

• Brand Name: Clareon Toric 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: 50693676
• Report Number: 9612169-2026-02024
• Device Sequence Number: 13160683
• Product Code: MJP
• UDI-Device Identifier: 00380652410731
• UDI-Public: (01)00380652410731(17)280206(11)240208(10)25794583
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNW0T5
• Device Lot Number: 25794583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 02/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown