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

Model Number	TFNT40
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are 2 medical device reports for this event.This report is for the left eye.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Information received via surgeon on (b)(6) 2021 consumer complained of glare in both eyes.Vision had dropped to 20/25 ou.Returned 1 week later and felt like his vision was worse after yag and was documented at 20/30.Patient was examined and noted some spots and mild haze/pc wrinkles.Doctor performed a yag pc but noted afterwards that the spots on the iol.There were spots on the left iol.Patient returned 1 week later with no improvement in vision or symptoms.Deposits were still present.Attempted to do low-power yag just anterior to iol os with some mild success.Was able to yag away some of the spots but avoided the central spot.It was reported by surgeon that toric lens rotated after surgery and was repositioned 1 month later.This file represents left eye.No further information available.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12094939
• Report Number: 1119421-2021-01291
• Device Sequence Number: 11800904
• Product Code: MFK
• UDI-Device Identifier: 00380652415972
• UDI-Public: 00380652415972
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40U160
• Device Lot Number: 12684027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR