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

Model Number	TFAT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced va flux, cloudy va, unclear and clinical reason for explant being subjective visual disturbance.The iol was explanted and exchanged for an unknown atiol following the initial implant procedure.Additional information has been requested and received stating that pt underwent a yag in jan 2023 and the lasik march of 2023 in the left eye after the initial implant.These procedures were done to see if they would alleviate patients complaints with her left eye, after much consideration, it was agreed upon that an iol exchange to a monofocal iol was her best option.In the surgeon's opinion what caused the event was subjective visual concerns, patients visual acuity was great, she just couldn't adjust to the modality of the multifocal.Lens was exchanged with a non company lens.Symptoms resolved.Surgeon's prognosis was, so far she's only been seen on 4/3 for the 1 day post op, healing well, but not enough info yet.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated, the product met release criteria.The account indicated, the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.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 company lens(1.50cyl), 16.5 diopter (add power +2.2/+3.2) lens was replaced with a non-company, monofocal, 15.5 diopter lens model.The account indicated, the product was not available to evaluate.Additional information was provided, that in the surgeon's opinion, the product did not cause or contribute to the event.It was reported, the surgeon believed, "subjective visual concerns.Patient's visual acuity was great, just couldn't adjust to the modality of the multifocal".Due to the exchange of a toric multifocal lens to a non-toric 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.Due diligence, has been performed in an attempt to obtain further information on this event.File will be reopened, if new information or the sample is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 19221980
• Report Number: 1119421-2024-00830
• Device Sequence Number: 12488688
• Product Code: MFK
• UDI-Device Identifier: 00380652418638
• UDI-Public: 00380652418638
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2024
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 03/14/2026
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.165
• Device Lot Number: 15166456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• 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; RPL B+L LI61AO SN (B)(6) D 15.5.; TOTALVISC OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female