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

Model Number	TFNT00
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported that, six months after intraocular lens implantation surgery, the lens had glistening.The lens still remains in the patient's eye.The visual acuity of patient was decreased but patient was not dissatisfied.The physician is currently waiting to see if the lens needs to be explanted.
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.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Correction: on follow-up mdr the fda eval method code b20 was not included inadvertently.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Photo review: one slit lamp image was provided and reviewed.The image is highly magnified showing an area of diffuse refractile bodies where it is difficult to determine the location of the bodies or more information based on the image.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.The image review was inconclusive.Information was provided that the patient is subjectively not dissatisfied.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: 18225536
• Report Number: 1119421-2023-02048
• Device Sequence Number: 15003312
• Product Code: MFK
• UDI-Device Identifier: 00380652357814
• UDI-Public: 00380652357814
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2024

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: 11/11/2025
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.240
• Device Lot Number: 15114376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 02/04/2024; 03/19/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 03/01/2024; 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• 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