MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Visual Impairment (2138); Insufficient Information (4580)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported following an intraocular lens (iol) implant procedure, the patient was intolerance to lens.The lens was explanted and replaced with monofocal lens in a secondary procedure.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Correction: on initial mdr the patient code of e0839, e0116 were missed.It should have been submitted in the initial mdr.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a (serious injury).The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and it states that due to the residual astigmatism and patient intolerance, the patient experienced headaches and was not achieving good visual acuity.As a result, the lens was exchanged to monofocal iol was exchanged for the different lens model with same diopter power indicating the correct lens power was not implanted initially.There is no reported defect or fault with the iol.There are two medical reports associated with this patient.This file belongs to right eye.

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
• Common Device Name: 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 ; 8007579780
• MDR Report Key: 25124138
• Report Number: 1119421-2026-00996
• Device Sequence Number: 10729146
• Product Code: POE
• UDI-Device Identifier: 00380652422031
• UDI-Public: (01)00380652422031(17)290327(11)240329(10)15829783
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: DFT415
• Device Catalogue Number: DFT415.190
• Device Lot Number: 15829783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 03/29/2024
• 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
• Patient Sex: Unknown