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

Model Number	TFAT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Visual Impairment (2138)
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 have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported explantation of an intraocular lens (iol) due to the patient being unhappy with results and no improvement with visual acuity.The patient reported "vision is worse." the iol was replaced with a monofocal lens.Additional information indicated that the patient had meibomian gland dysfunction.Further information was requested; however, additional information has not been received.
Additional Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received that patient¿s exchanges were initially planned for june, but at that time explantation was not done.

• 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: 12110668
• Report Number: 1119421-2021-01316
• Device Sequence Number: 4615444
• Product Code: MFK
• UDI-Device Identifier: 00380652418737
• UDI-Public: 00380652418737
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2025
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.215
• Device Lot Number: 15050070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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