MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon Vivity Toric Extended Vision Hydrophobic IOL w/AutonoME Delivery System; Lens, Intraocular, Toric Optics

Model Number	CNAET4
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health professional reported that during an intraocular lens (iol) implantation procedure the lens did not engage/work not implanted therefore used unspecified back up lens and procedure was completed on the same day.Additional information has been requested but is not available at the time of this report.
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 Vivity Toric Extended Vision Hydrophobic IOL w/AutonoME Delivery System
• 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: 50696617
• Report Number: 9612169-2026-02026
• Device Sequence Number: 13165375
• Product Code: MJP
• UDI-Device Identifier: 00380652460101
• UDI-Public: (01)00380652460101(17)280705(11)240707(10)25875387
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNAET4
• Device Catalogue Number: CNAET4.205
• Device Lot Number: 25875387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 07/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Amvisc OVD used
• Patient Sex: Unknown