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	10/17/2022
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 clinical coordinator reported that following an intraocular lens (iol) implant procedure, the patient experienced unexpected visual outcome.The iol was explanted and exchanged in a secondary procedure for monofocal lens.Additional information has been requested.
Event or Problem Description
Additional information has been requested and received stated that there was no patient harm and the patient issue was resolved and the surgeon prognosis was excellent.
Additional Manufacturer Narrative
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 lens 23.0 diopter (add power +2.2/+3.2) lens was replaced with an unspecified, monofocal lens model.The reported reason for the exchange was "visual outcome not as expected" 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.Follow up attempts were made for more details of the event.No additional information has been provided at this time.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: 16361361
• Report Number: 1119421-2023-00295
• Device Sequence Number: 15142896
• Product Code: MFK
• UDI-Device Identifier: 00380652429771
• UDI-Public: 00380652429771
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

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: 04/30/2024
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.230
• Device Lot Number: 12715238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALCON FORCEPS; ANIKAVISC; B&L L1615E 23.0 4243513004; MONARCH CARTRIDGE D; MONARCH INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown