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	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted lens was returned in the replacement lens case.Solution was dried on the lens.The anterior optic surface was scratched.Product history records were reviewed and the documentation indicated the product met release criteria.Information indicated the use of a qualified cartridge and handpiece.A non-qualified viscoelastic was indicated.The root cause was determined to be most likely unrelated to the lens.The initial report was for blurred visual acuity optics, residual cylinder, and s/p lasik likely source of blur.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 information provided by the facility indicate that in the surgeon's opinion, the lens did not cause or contribute to the event.The cause was written as optics, residual cylinder and s/p lasik.Information was provided that the company lens was removed and replaced with a non-company lens.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non health care professional reported following the intraocular lens implantation the patient had experienced blurry vision, residual cylinder.The lens was explanted in a secondary surgery and was replaced with a different lens.

• 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: 13421391
• Report Number: 1119421-2022-00153
• Device Sequence Number: 17615556
• Product Code: POE
• UDI-Device Identifier: 00380652424639
• UDI-Public: 00380652424639
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2022

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: 09/15/2025
• Device Model Number: DAT015
• Device Lot Number: 15099688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2020
• 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: HEALON; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; ZA9003+20.0 SN (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female