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 Codes	Blurred Vision (2137); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.The lens is cut in half, typical of insertion and removal from the eye.One haptic is broken in the gusset area (not returned).Scratches and cracks are observed on the lens.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge and handpiece.The file also indicates the use of a non-qualified viscoelastic.The product investigation could not identify a root cause for the reported complaint.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.The file indicates the clinical reason for explant is patient didn't adapt to lens.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 halos around the lights during day and night and blurry distance vision.Hence the lens was explanted and replaced with another lens in a secondary procedure.The clinical reason for explant was patient did not adapt to lens.

• 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: 17905235
• Report Number: 1119421-2023-01731
• Device Sequence Number: 15362448
• Product Code: MFK
• UDI-Device Identifier: 00380652429733
• UDI-Public: 00380652429733
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2023

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: TFAT00
• Device Catalogue Number: TFAT00.210
• Device Lot Number: 15382965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female