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

Model Number	DFT315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Macular Edema (1822); Visual Impairment (2138)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
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 health care professional reported that a patient was not completely satisfied with the vision; the vision was not as good as hoped.The patient apparently also had macular edema after the operation.But he was also dissatisfied with the cost of the surgery.Additional information has been requested and received stating that patient experienced hyperopia and did not respond in a goal directed manner.Had been on dexa gentamicin eye drops 5x daily.Surgery for right eye was planned for 17-may.Additional information received stating that the diagnosis was found to be epithelial edema.Patients symptoms had been restored.Eye drops was used as a medical intervention.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.The file states the patient is not completely satisfied with their vision or the cost of the surgery.Due diligence has been performed in an attempt to obtain further information on this event.The file will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18967367
• Report Number: 1119421-2024-00546
• Device Sequence Number: 15022791
• Product Code: POE
• UDI-Device Identifier: 00380652421706
• UDI-Public: 00380652421706
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2024

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 Expiration Date: 08/21/2026
• Device Model Number: DFT315
• Device Lot Number: 15251406
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 03/26/2024; 05/13/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/23/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2021
• 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: INFLANEFRAN.; ODM.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Female