MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon Vivity Extended Vision Hydrophobic IOL w/AutonoME Delivery System; Extended depth of focus intraocular lens

Model Number	CNAET0
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A non-healthcare professional reported that, during intraocular lens implantation surgery, the trailing haptic was stuck posteriorly under the iol.This occurred after the lens was injected into the eye.The same lens was used, as the surgeon managed to pry the haptic away.The patient was not harmed.The procedure was completed on the same day.Additional information has been requested but is not available at the time of this report.

• Brand Name: Clareon Vivity Extended Vision Hydrophobic IOL w/AutonoME Delivery System
• Common Device Name: Extended depth of focus intraocular lens
• 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: 50754908
• Report Number: 9612169-2026-02058
• Device Sequence Number: 15870008
• Product Code: POE
• UDI-Device Identifier: 00380652406321
• UDI-Public: (01)00380652406321(17)280729(11)240731(10)25898298
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: CNAET0
• Device Lot Number: 25898298
• 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: 09/14/2026
• Date Device Manufactured: 07/31/2024
• 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
• Patient Sex: Unknown