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

Model Number TFNT00

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Visual Disturbances (2140)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).

Event Description

A patient reported glare, rings and starbursts following bilateral intraocular lens implantation.He noted difficulty with night driving and trouble reading street signs.The patient consulted with his surgeon and discussed bilateral iol exchanges.Additional information has been requested however, further information has not been received.There are two medical device reports associated with this patient.This report is for the left eye.

Manufacturer Narrative

Corrected information provided in a.1.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information was received, indicating the lens was explanted, due to the patient's report of "glare and quality of life is suffering".The lens was exchanged for an alternative multifocal lens.

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Type of Device: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10907434
• MDR Text Key: 218497087
• Report Number: 1119421-2020-01780
• Device Sequence Number: 1
• Product Code: MFK
• Combination Product (y/n): N
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

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
• Device Operator: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U185
• Device Lot Number: 15019446
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/26/2020
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR