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

Model Number	DAT015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following implantation of an intraocular lens (iol) the distance vision beyond around 18¿ is still fuzzy as well as closeup.Additional information was requested and received stating lens get dry during awakening hours, but after use of refresh on a regular basis which helps for a while.Computer screens at about 31¿ begins to get in the fuzzy zone & there on out, my vision is fuzzy and not being able to recognize people from about 20+ feet out is somewhat frustrating.Additional information was requested and received stating experiencing little haze 2 months ago & said if it¿s still there.Ophthalmologist can fix it with laser surgery, but he also said that could affect the vision process.The patient wait until around december since right eye was done june 9th.There are two medical device reports associated with this patient.This report is associated with the left eye.
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 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 manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is:(b)(4).
Event or Problem Description
Additional information has been received and stated that the patient experienced blurry vision at all levels and the patient underwent for laser treatment for the capsules.

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION UV ABSORBING 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: 15247294
• Report Number: 1119421-2022-01792
• Device Sequence Number: 20295501
• Product Code: POE
• UDI-Device Identifier: 00380652424622
• UDI-Public: (01)00380652424622(17)250907(11)200908(10)15095956
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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: 09/07/2025
• Device Model Number: DAT015
• Device Lot Number: 15095956
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 10/01/2022; 08/07/2024
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 10/27/2022; 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: REFRESH AT'S
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Male