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

Model Number	TFNT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that during a cataract extraction with intraocular lens (iol) implant procedure, the complication happened upon implanting the lens.A sulcus lens was used, and surgery was completed on the same day.There was patient contact, but no patient harm.  additional information was requested and received, stating that the complication experienced by the patient was posterior capsule rupture.The physician did not have strong evidence that he suspects the iol.
Additional Manufacturer Narrative
A sample device was not returned for analysis.All product and batch history records are quality reviewed prior to product release.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.No signs of handling.No damage is observed to the lens.All product and batch history records are quality reviewed prior to product release.Qualified associated products were indicated, yet the lens shows no signs of being used.No damage is observed to the lens.The product investigation could not identify a root cause for the reported complaint.Information in the file states the doctor did not see any strong evidence the iol was at fault.Information in the file states there was patient contact.The lens has no signs of being used.An unspecified sulcus lens was used as a replacement lens.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: 17296546
• Report Number: 1119421-2023-01235
• Device Sequence Number: 17887057
• Product Code: MFK
• UDI-Device Identifier: 00380652357753
• UDI-Public: 00380652357753
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2023

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 Model Number: TFNT00
• Device Catalogue Number: TFNT00.210
• Device Lot Number: 15477210
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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: DISCOVISC; MONARCH III CARTRIDGE D; MONARCH III INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male