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	CNAET3
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during the intraocular lens (iol) implantation surgery, the trailing haptic folded wrong.The surgery was completed on the same day.Additional information was received stating that, the trailing haptic was straight.The lens was left implanted but the trailing haptic has a tip sheared off.The patient was doing fine and being monitored.
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: 50929172
• Report Number: 9612169-2026-02224
• Device Sequence Number: 21223346
• Product Code: MJP
• UDI-Device Identifier: 00380652459785
• UDI-Public: (01)00380652459785(17)290225(11)250227(10)25992798
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: CNAET3
• Device Catalogue Number: CNAET3.225
• Device Lot Number: 25992798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 02/27/2025
• 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
• Patient Sex: Unknown