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

Model Number	TFNT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	02/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported explantation of an intraocular lens (iol) with a clinical reason of anisometropia.The patient was "not seeing clearly." additional information as been requested; however, further information has not been received.
Additional Manufacturer Narrative
The lens was returned loose with the lens case lid.Solution is dried on the lens.The lens was cleaned with lphse.Scratches are observed on the optic surface.A power and resolution test was performed.The resolution test results are acceptable.Product history records were reviewed and the documentation, indicated the product met release criteria.Qualified associated products were indicated.The root cause for the reported events could not be determined.A malfunction has not been indicated, or information provided that the lens was the cause of the event.The 12.0 diopter (add power +2.2/+3.2) lens was replaced with an 11.5 diopter lens.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11556771
• Report Number: 1119421-2021-00628
• Device Sequence Number: 14472076
• Product Code: MFK
• UDI-Device Identifier: 00380652414838
• UDI-Public: 00380652414838
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 01/31/2024
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U120
• Device Lot Number: 12685733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/24/2021
• 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: ACRYSOF IQ RESTOR IOL; MONARCH III IOL INJECTOR; MONARCH III IOL, CARTRIDGE D; MONARCH IOL CARTRIDGE D; MONARCH IOL INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention