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	08/23/2022
Type of Reportable Event	Serious Injury
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
A nurse reported following an intraocular lens (iol) implant procedure, the patient could not adjust.The lens was explanted and replaced with monofocal lens in a secondary procedure.The clinical reason for the explant was mechanical failure to adapt.Additional information was requested, but further no information was available.
Additional Manufacturer Narrative
The lens was returned in a small glass container filled with a clear liquid and what appears to be a plastic cover.The optic was cut into pieces, typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.The file indicated the use of qualified associated products.Information was provided that in the surgeon's opinion, the lens did not cause or contribute to the event.In the surgeon's opinion the cause of the event was the patient could not adjust to the lens.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 the multifocal company 21.0 diopter, add power +2.2 & 3.2 lens model was replaced with a non-company monofocal (20.0) 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.No additional information has been provided at this time.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.There are two medical device reports associated with this patient.This report is associated with the right eye.

• 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: 15926146
• Report Number: 1119421-2022-02584
• Device Sequence Number: 5225718
• Product Code: MFK
• UDI-Device Identifier: 00380652429733
• UDI-Public: 00380652429733
• 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: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2022

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: 03/16/2025
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.210
• Device Lot Number: 15050172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2020
• 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, CARTRIDGE D.; MONARCH III, INJECTOR.; ORA SYSTEM.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female