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	Blurred Vision (2137)
Date of Event	06/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that, after intraocular lens implantation surgery, the patient experienced extremely blurred vision and noticed only subtle improvements.The patient consulted the doctor and the doctor recommended a degree of near, far and axis.The patient can see at a distance of 1.5m and from there the vision gets shaded.The patient does not have clear near vision and he could not read shampoo label or cell phone.Additional information was requested, but no further information is available.
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 was not provided.The root cause cannot be determined for the reported complaint of ¿blurry vision¿.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.Per the instructions for use (ifu): the company lens is indicated for primary implantation for the visual correction of aphakia in adult patients with < 1.00 d of preoperative corneal astigmatism, in whom a cataractous lens has been removed by extracapsular cataract extraction.The lens mitigates the effects of presbyopia by providing an extended depth of focus.Compared to an aspheric monofocal lens, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity.Accurate biometry is essential for successful visual outcomes.Information was provided from the consumer in the initial report description that the doctor promised he would not need to wear glasses.Currently patient reports extremely blurred vision, has noticed subtle improvements.Consumer has been to the doctor, and the doctor recommended a degree of near, far and axis.He can see at a distance of 1.5m and from there it starts to get shaded.Up close he has no clear vision (example: he can't read shampoo label or cell phone.A second post op follow up with the surgeon is planned in two months.If additional information becomes available, the file will be reopened and updated.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: 17582776
• Report Number: 1119421-2023-01482
• Device Sequence Number: 3600343
• Product Code: POE
• UDI-Device Identifier: 00380652421294
• UDI-Public: 00380652421294
• 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
• Report Date (Section B): 08/21/2023

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 Model Number: DFT015
• Device Lot Number: 15301265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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: Other
• Patient Age: 40 YR
• Patient Sex: Male