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

Model Number	TFAT00
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A clinical supervisor reported following an intraocular lens (iol) implant procedure, the lens was explanted and replaced with another lens in a secondary procedure.The clinical reason for the explant was intraocular lens disfunction.Additional information was requested, but further no information was available.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating there was no patient harm and patient was not hospitalized as a result of this event.
Additional Manufacturer Narrative
The account indicated the use of a qualified cartridge.The product investigation could not identify a root cause for the reported complaint.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.Information was provided that the multifocal company, 22.0 diopter (add power +2.2/+3.2) lens was replaced with a non-company, 22.5 diopter, monofocal lens model.The account did not provide a specific complaint against the product.The product was not available for evaluation.Due to the exchange of a multifocal lens to a monofocal lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.Additional information was provided that the patient had prior s/p lasik surgery.Follow up attempts were made for more details of the event.No additional information has been provided at this time.File will be reopened when more information is received.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: 16309994
• Report Number: 1119421-2023-00248
• Device Sequence Number: 6075019
• Product Code: MFK
• UDI-Device Identifier: 00380652429757
• UDI-Public: 00380652429757
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.220
• Device Lot Number: 15391351
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• 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: MONARCH III, CARTRIDGE C
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female