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

Model Number	TFNT00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
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 physician reported that during implantation of an intraocular lens (iol) a dot was observed on the lens.There was no patient harm.Additional information was requested.
Additional Manufacturer Narrative
The product was returned.The returned lens matches the provided photo(s).Solution was dried on the lens.A scratch is observed on the anterior surface of the optic.The reported ¿dot¿ was not found upon return.The product investigation could not identify a root cause.The reported ¿small thread¿ was not observed.The particle may have been lost/shifted off the lens during return shipment.There are no other complaints in this lot.Investigation has been completed based on current information.Based on our current tracking, there are no adverse trends for this reported complaint.No further action warranted at this time.The lens was not returned.A photo was available.The lens case was shown disassembled.The lid was mylar facing up next to the lens case base.The lens was positioned incorrectly and posterior surface up inside the #78(iw) lens case.The reported "dot" could not be observed in the photo.The photo was magnified to attempt better viewing of the reported complaint.The quality of the photo decreased upon greater magnification.The reported "dot" / foreign material could not be observed in the photo.Product history records were reviewed and documentation indicated the product met release criteria.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: 13768527
• Report Number: 1119421-2022-00466
• Device Sequence Number: 5008749
• Product Code: MFK
• UDI-Device Identifier: 00380652357722
• UDI-Public: 00380652357722
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.195
• Device Lot Number: 15118577
• 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: 02/21/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2020
• 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
• Patient Sex: Unknown