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 Code	Visual Disturbances (2140)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that, after intraocular lens implantation surgery, the patient did not adapt to the lens and saw diagonal lines.Hence the lens was explanted and replaced with monofocal lens in a secondary procedure.The patient was not hospitalized as a result of this event and there was no patient harm.
Additional Manufacturer Narrative
The lens was returned inside a non-company lens case.The lens information has been removed from the lens case.Viscoelastic was observed on the lens.The lens was scratched.The lens was cleaned with klrp.Power and resolution were verified.The lens met specification for power and resolution.A qualified handpiece and cartridge were indicated with a non-qualified viscoelastic.The lens met specification for power and resolution.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.It cannot be determined if the observed scratches were present before the explant or if they occurred during the lens removal.The instruction for use (ifu) instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Information was provided that the company, 22.0 diopter, (1.5 extended depth of focus) lens was replaced with a non- company, 21.5 diopter monofocal lens model.The exchange from an extended depth of focus lens to a monofocal lens may indicate the monofocal lens was an improved choice for the patient's visual needs.The manufacturer internal reference number is: (b)(4).

• 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: 17905099
• Report Number: 1119421-2023-01730
• Device Sequence Number: 8224681
• Product Code: POE
• UDI-Device Identifier: 00380652424677
• UDI-Public: 00380652424677
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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: 09/16/2025
• Device Model Number: DAT015
• Device Lot Number: 15099700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2020
• 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 INJECTOR; MONARCH III, CARTRIDGE D; ZA9003+21.5SN: (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male