MAUDE Adverse Event Report: Alcon Research, LLC - Huntington Clareon Vivity Extended Vision UV Absorbing IOL; Extended depth of focus intraocular lens

Model Number	CCWET0
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following intraocular lens (iol) implantation, a capsular tear occurred in the capsular bag, resulting in lens migration.Consequently, the iol was removed and replaced with an unspecified anterior chamber lens during a secondary procedure.No further details are expected, as the reporter has no more information available.
Additional Manufacturer Narrative
The product was not returned for analysis.A batch record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the medical device file were met.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

• Brand Name: Clareon Vivity Extended Vision UV Absorbing IOL
• Common Device Name: Extended depth of focus intraocular lens
• Manufacturer (Section D): Alcon Research, LLC - Huntington; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): Alcon Research, LLC - Huntington; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; +1(800)757-9780
• MDR Report Key: 50099457
• Report Number: 1119421-2026-01602
• Device Sequence Number: 13330059
• Product Code: POE
• UDI-Device Identifier: 00380652405751
• UDI-Public: (01)00380652405751(17)281013(11)241015(10)15938438
• 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,Followup
• Report Date (Section B): 08/21/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: CCWET0
• Device Lot Number: 15938438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/21/2026
• Date Device Manufactured: 10/15/2024
• 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; Other
• Patient Sex: Unknown