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

Model Number	TFNT00
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/30/2024
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 pharmacist reported that following an intraocular lens (iol) implant procedure, lens anterior surface with deposits that are causing significant visual impairment to the patient.Additional information was received stating significant visual decline (4/10) whereas operative recovery was very good (10/10).Deposits on the anterior surface of the implant, despite good opening of the anterior rhexis.Measures were taken by cleaning the anterior surface of the implant with minimal yag laser power.Lab data: best corrected visual acuity pre-op? 6/10weak parinaud 3 - best corrected visual acuity post-op? 10/10 parinaud 1.5.- best preoperative uncorrected visual acuity? 4/10 weak.- postoperative uncorrected visual acuity? 9/10 parinaud 2 ; cycloplegic refraction -0.25 (-0.50 à 60°) 10/10.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.Information was provided that the patient had a decline in vision from 10/10 to 4/10.Deposits were observed on the anterior surface of the implant, despite good opening of the anterior rhexis.Cleaning of the anterior surface of the implant with minimal (yagyttrium aluminium garnet) laser power was conducted.Patient will be monitored for regrowth.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX 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: 19509863
• Report Number: 1119421-2024-01118
• Device Sequence Number: 14344108
• Product Code: MFK
• UDI-Device Identifier: 00380652357807
• UDI-Public: (01)00380652357807(17)270829(11)220831(10)15481518(21)15481518076
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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 Model Number: TFNT00
• Device Catalogue Number: TFNT00.235
• Device Lot Number: 15481518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 08/28/2024
• Date Device Manufactured: 08/31/2022
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female