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	Dry Eye(s) (1814); Visual Disturbances (2140)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-health care professional reported that following an intraocular lens (iol) implant procedure, patient states since they took the patch off she sees a blurred, smudge on the periphery of her vision.When patient looks straight it is pretty clear, but when patient looks left or right she sees the smudge spot.Patient surgeon saw her at one day post op and told her everything was fine but her eyes were dry and to use artificial tears.Additional information was requested.
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).
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Associated product information is unknown.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.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.The reporter was the patient.The reporter stated that the surgeon indicated at one day post op that everything was fine but they had dry eyes and to use artificial tears.The reporter was informed by the surgeon to return in 3 months as the surgeon could not do anything until the eye was healed.The consumer was advised to speak to their surgeon regarding the issues they are experiencing or seek a second opinion.Company is unable to provide medical advice or recommendations.Consumer was asked to contact company should additional details become available.Educational materials were emailed to the patient.No further information has been provided.File will be reopened if new information is received.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: 19664019
• Report Number: 1119421-2024-01248
• Device Sequence Number: 6540294
• Product Code: POE
• UDI-Device Identifier: 00380652421126
• UDI-Public: (01)00380652421126(17)260808(11)210810(10)15247489(21)15247489062
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 08/08/2026
• Device Model Number: DFT015
• Device Lot Number: 15247489
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 08/26/2024
• Date Device Manufactured: 08/10/2021
• 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: ARTIFICIAL TEARS
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown