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 Code	Visual Disturbances (2140)
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.There have been no other complaints reported in the lot number.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported following an intraocular lens (iol) implantation, the patient could not tolerate visual disturbances at night, further clarified as glare.The iol was exchanged for another lens model in a secondary procedure and a suture was placed.The secondary procedure was completed with no complications to the patient additional information was requested.
Event or Problem Description
Additional information was received stating the patient was not hospitalized for the event and there was no patient harm.
Additional Manufacturer Narrative
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: 12434408
• Report Number: 1119421-2021-01695
• Device Sequence Number: 14384156
• Product Code: MFK
• UDI-Device Identifier: 00380652416061
• UDI-Public: 00380652416061
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/27/2021

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: 04/30/2024
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40U205
• Device Lot Number: 12711518
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 09/27/2021
• 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: 10-0 NYLON SUTURE; ACRYSOF IQ VIVITY IOL; DUOVISC; EPI-SHUGARCAINE; LID SPECULUMS; MIOCHOL; MONARCH III D CARTRIDGE; MONARCH III INJECTOR; MST SCISSORS; SIDE PORT KNIFE; UNSPECIFIED ANTIBIOTIC OINTMENT; UNSPECIFIED VISCOELASTIC; 10-0 NYLON SUTURE; ACRYSOF IQ VIVITY IOL; EPI-SHUGARCAINE; LID SPECULUMS; MIOCHOL; MST SCISSORS; SIDE PORT KNIFE; UNSPECIFIED ANTIBIOTIC OINTMENT; UNSPECIFIED VISCOELASTIC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR