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 Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device 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 physician reported that following an intraocular lens (iol) implant procedure, the patient corrected visual acuity (cva) was decreased from 0.6 to 0.3 and 9 months after the surgery the patient's uncorrected visual acuity (ucva) was 0.15.There was no improvement in distance or near vision.Yag laser treatment was not performed.Doctor wants to wait and see if the patient's vision will improve with time for iol exchange.But the vision was not improved and iol was explanted and exchanged with non company lens 1 year 5 months following the initial procedure.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned.The lens has been cut into two pieces across the optic.The power and resolution could not be evaluated due to the extensive optic damage.Associated products were not provided.It is unknown if qualified associated products were used.The product investigation could not identify a root cause for the reported complaint.The lens was returned in pieces.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the company 015, 19.5 diopter, (extended 1.5 diopters of focus) was replaced with a non-company monofocal lens.The exchange from an extended depth of focus lens to a monofocal lens may indicate the replacement was an improved choice for the patient's visual needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY 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: 17728888
• Report Number: 1119421-2023-01592
• Device Sequence Number: 6164444
• Product Code: POE
• UDI-Device Identifier: 00380652421225
• UDI-Public: 00380652421225
• 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: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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: 01/07/2026
• Device Model Number: DFT015
• Device Lot Number: 15126675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male