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

Model Number	TFAT50
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Visual Impairment (2138); Fibrosis (3167)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an uncomplicated cataract extraction with intraocular lens (iol) implant procedure, the axis of the iol is off.At six weeks postoperative, the patient¿s cornea is clear and there is no cystoid macular edema (cme).There is some peripheral fibrosis over the anterior surface of the iol.The patient has been offered an iol rotation or iol exchange and would prefer the rotation at this time.The physician cannot explain why he can¿t fully correct the patient¿s visual acuity.Additional information has been requested.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12648057
• Report Number: 1119421-2021-01941
• Device Sequence Number: 1427972
• Product Code: MFK
• UDI-Device Identifier: 00380652419826
• UDI-Public: 00380652419826
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TFAT50
• Device Catalogue Number: TFAT50.230
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR