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	Visual Impairment (2138)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported following an intraocular lens implant procedure, the patient was not able to adapt with the lens.The lens was exchanged in a secondary procedure.Additional information ahs been requested.
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 1 other complaint reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received indicated that, in the surgeon's opinion, there was no quality issue with the lens that caused or contributed to the event.No patient harm was reported.
Additional Manufacturer Narrative
Only a portion of the lens was returned in a clear liquid inside a small glass container.The optic was cut into pieces, typical of insertion and removal.The other cut portions of the lens were not returned for evaluation.Power and resolution testing could not be conducted due to the extensive optic damage.Qualified associated products were indicated.Power and resolution testing could not be conducted due to the extensive optic damage.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Information was provided in the file that in the surgeon's opinion, there was no quality issue with the lens that caused or contributed to the event.It was indicated that ¿patient unable to neuro adapt to intraocular lens".The multifocal company lens, 20.0 diopter, add power +2.2 & 3.2 lens was exchanged for a non-company monofocal intraocular lens.Due to the exchange of a multifocal lens to a monofocal lens may have been an improved choice for the patient's vision needs.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
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: 15247356
• Report Number: 1119421-2022-01793
• Device Sequence Number: 14904918
• Product Code: MFK
• UDI-Device Identifier: 00380652429719
• UDI-Public: 00380652429719
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2023

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: 02/18/2025
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.200
• Device Lot Number: 15019528
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 09/26/2022; 08/18/2023
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 10/23/2022; 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2020
• 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 IOL, CARTRIDGE D.; MONARCH III IOL, INJECTOR.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female