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

Model Number	DFT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Insufficient Information (4580)
Date of Event	06/18/2024
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 health care professional reported with a description of explantation of the lens.Additional information was requested.
Additional Manufacturer Narrative
Correction information was provided in b.3.Additional information was provided in a.2., b.5., b.6., b.7., d.6.A., d.6.B., d.10.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received as the patient expressed dissatisfaction with her lenses despite an objectively successful surgical outcome.Over several months, she continued to report severe glare and dysphotopsia.Due to these persistent symptoms, the lenses were recently explanted and replaced with lenses from the same manufacturer but with a different diopter.Following the replacement, there have been no further adverse impacts on the patient.There are two medical device reports associated with this patient.This report is associated with the left eye.

• Brand Name: ACRYSOF IQ VIVITY 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: 23100877
• Report Number: 1119421-2025-02531
• Device Sequence Number: 9225961
• Product Code: POE
• UDI-Device Identifier: 00380652421263
• UDI-Public: (01)00380652421263(17)280731(11)230803(10)15691398
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 01/12/2026

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: DFT015
• Device Catalogue Number: DFT015.215
• Device Lot Number: 15691398
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 01/12/2026
• Date Device Manufactured: 08/03/2023
• 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: CLAREON IOL; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; OVD: ZEISS VISTHESIA 1%
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female