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	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	11/10/2023
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 consumer reported that after undergoing phacoemulsification phacectomy, with implantation of the extended focus intraocular lens (iol), consumer experienced blurring and defocusing of the images seen at medium and long distances.There were no complications either during or after surgical procedure, which was duly monitored by the surgeon.The surgeon carried out retinal mapping and optical coherence tomography, macula monocular exams, with the aim of verifying the probable clinical factors that could be causing this complaint of blurred vision at medium and long distances.The surgeon analyzed the reports of the aforementioned examinations and found no factor related to the complaint.Furthermore, the surgeon examined and verified the fixation and centering of the implanted lenses several times.Faced with this situation, the ophthalmologist prescribed glasses to correct the visual impairment not corrected by the implanted lenses, since clinically it would not be advisable to replace them.More than three months after the lens was implanted, it was still causing shadows around objects and letters and blurring of vision.In addition, from time to time, there was a sort of "opaque curtain" that moved horizontally, symptomatically, in front of the eyeball.The consumer could see the lights of cars, lampposts and road signs full of blurred circles and reflections, everything completely out of focus.And in this respect, it was becoming increasingly difficult to drive cars.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.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 remains implanted.Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The reporter was the patient.Their next appointment is scheduled for (b)(6) 2024.Patient did not give permission for contact with the hcp.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: 18845438
• Report Number: 1119421-2024-00429
• Device Sequence Number: 8332906
• Product Code: POE
• UDI-Device Identifier: 00380652422093
• UDI-Public: 00380652422093
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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: 06/14/2025
• Device Model Number: DFT415
• Device Lot Number: 15077857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Male