MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFAT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, lens was explanted at secondary procedure due to patient experienced blurred vision.The clinical reason was reported to be mechanical complication.The iol was replaced with other company lens approximately three months after initial procedure.There was no patient harm.
Additional Manufacturer Narrative
The lens was returned inside a plastic specimen cup with a screw top lid.Solution was dried on the lens.The lens was cleaned with klrp to evaluate.No damage was observed to the lens.Power and resolution were verified by an engineering technician.The lens met specification for power and resolution.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic combination.The root cause cannot be determined for the reported complaint of blurred vision.The lens was returned and no damage was observed.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 power and resolution of the returned lens was verified by an engineering technician.The lens met specification for power and resolution for a company 24.5 diopter (add power +2.2/+3.2 diopter) lens.Information was provided that indicated the company 24.5 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non- company extended depth of focus 26.0 diopter lens.This information may suggest that the replacement lens model and higher diopter was an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• 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: 19277410
• Report Number: 1119421-2024-00889
• Device Sequence Number: 18040542
• Product Code: MFK
• UDI-Device Identifier: 00380652429801
• UDI-Public: 00380652429801
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: 03/03/2025
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.245
• Device Lot Number: 15052725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• 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: MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female