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

Model Number	CCAET0
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, the leading haptic was folded backwards and stuck to back of optic; pulling it loose with a sinskey instrument resulted in a peripheral posterior capsule defect.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 Extended Vision UV Absorbing 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: 50945888
• Report Number: 9612169-2026-02241
• Device Sequence Number: 13145171
• Product Code: POE
• UDI-Device Identifier: 00380652406765
• UDI-Public: (01)00380652406765(17)280407(11)240409(10)25835203
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: CCAET0
• Device Lot Number: 25835203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 04/09/2024
• 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: Sinskey instrument.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown