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

Model Number	TFNT40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
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.  there have been no other complaints reported in the lot number.  additional information has been requested.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that following intraocular lens (iol) implantation, the patient experienced blurry vision.The iol was explanted for clinical reason of refractive error.Additional information was requested.
Event or Problem Description
Additional information was received an reported that iol was exchanged for the same lens model but half a diopter less power indicating the correct lens power was not implanted initially.There is no reported defect or fault with the iol.
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).

• 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: 11959976
• Report Number: 1119421-2021-01172
• Device Sequence Number: 3565953
• Product Code: MFK
• UDI-Device Identifier: 00380652416115
• UDI-Public: 00380652416115
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021

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: 08/31/2024
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40U230
• Device Lot Number: 12746848
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH CARTRIDGE D; MONARCH III INJECTOR; PROVISC OVD; MONARCH CARTRIDGE D; MONARCH III INJECTOR; PROVISC OVD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR