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

Model Number	TFNT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
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.There have been one other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A surgeon reported that following an intraocular lens (iol) implant procedure, the patient experienced poor vision and glare.The iol was exchanged for another lens with same diopter 1 month following the initial implant procedure.No further information available.
Additional Manufacturer Narrative
Additional information provided in b.5., d.9., h.3., h.6., and h.10.The lens was returned for evaluation.Solution is dried on the lens.The lens was returned cut in half, typical of insertion and removal from the eye.The haptics are twisted within the posts of the lens case.A scratch is observed on the optic of one half of the lens.A split is observed beside the cut area of one half of the lens.A power and resolution inspection could not be conducted due to extensive damage.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.A power and resolution inspection could not be conducted due to extensive damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.The lens was replaced with the same model and diopter.The patients condition has been resolved.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that, the patient symptoms were resolved.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 16292910
• Report Number: 1119421-2023-00241
• Device Sequence Number: 12400300
• Product Code: MFK
• UDI-Device Identifier: 00380652389921
• UDI-Public: 00380652389921
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: 10/31/2024
• Device Model Number: TFNT30
• Device Catalogue Number: TFNT30.175
• Device Lot Number: 12756579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown