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 Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	09/29/2022
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 no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported following an intraocular lens (iol) implant procedure, the patient experienced blurry vision at all distances.The lens was explanted in a secondary procedure.Additional information was requested and received stating the patient's cylindrical value increased post surgery.
Additional Manufacturer Narrative
Additional information provided in d.4., d.9., d.10,, h.3., h.6.And h.10.The lens was returned in a non-company lens case.Solution was dried on the lens.The lens was torn/split/cracked and smashed over and against the posts of the lens case.Power and resolution testing could not be conducted due to the extensive optic damage.The account indicated the use of a qualified associated cartridge and handpiece.The viscoelastic indicated is not qualified for use with this lens with any of the qualified lens/cartridge/handpiece combinations.Upon return, the lens was observed to be placed into the lens case incorrectly resulting in extensive damage.The product investigation could not identify a root cause for the reported complaint.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 that the multifocal 12.0 diopter (add power +2.2/+3.2) lens was replaced with a third party, 12.0 diopter, monofocal lens model.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).

• 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: 15939397
• Report Number: 1119421-2022-02610
• Device Sequence Number: 6346587
• Product Code: MFK
• UDI-Device Identifier: 00380652429559
• UDI-Public: 00380652429559
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/20/2023

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: 05/31/2024
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.120
• Device Lot Number: 12720632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2019
• 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: HEALON; IOL - ZA9003 +12.0 SN:(B)(6); MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female