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

Model Number	DFT015
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	07/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned.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 complaint was reported by the patient and the surgeon.Information was provided that the lens implantation procedure improved the patient's near vision.Capsulotomy was performed in both eyes, which worsened the vision of light points.Patient is using corrective lenses for distance.A consultation at another clinic indicated that the lenses were implanted slightly above the pupil axis.Hcp did not know if this can affect the occurrence of the reported symptoms.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient's vision in the near range has improved significantly, but in the middle and farther distances, it is worse than before the surgery.The patient experienced flares, halos, blurred vision, and dark areas to the side of the field of view.Additional information was requested and received, stating the patient underwent capsulotomy in both eyes, which worsened the vision of light points in the room.The patient sees rays around them of varying length.For intermediate and distant vision patients who have been using corrective glasses for about a month, mainly for driving and watching tv.The patient's vision is not resolved, and beyond 2-2.5 meters, the patient sees a slightly blurry image, which is worse than before the procedure.The patient sees color halos or rainbow stripes around distant lights.Lights at a distance of several meters have bright outlines.The lens implantation procedure improved the patients near vision, and the patient does not use glasses for reading.There are two medical device reports associated with this patient.This report is for right eye.
Event or Problem Description
Additional information was received, stating astigmatism appeared in the right eye, which was not present before implantation of lens.
Additional Manufacturer Narrative
Information was provided that patient has induced astigmatism in the right eye.The implanted company lens does not have a cylinder component and cannot impact astigmatism.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: 17058555
• Report Number: 1119421-2023-01025
• Device Sequence Number: 6956907
• Product Code: POE
• UDI-Device Identifier: 00380652421324
• UDI-Public: 00380652421324
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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: 08/30/2026
• Device Model Number: DFT015
• Device Lot Number: 15260883
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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 Sex: Unknown