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

Model Number TFNT40

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 07/26/2023

Event Type  Injury  

Event Description

A physician reported that the patient had a lens implanted, and upon examination the next day, the lens had rotated.The patient was taken back to the operating room, and the lens was repositioned by a degree of implantation.However, after a few days, the lens rotated again.Additional information has been requested and received.

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.The manufacturer internal reference number is: \ (b)(4).

Manufacturer Narrative

The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint of lens rotated.The lens remains implanted.Information was provided that the patient's current visual acuity is 0.5-0.6.The patient has another appointment in 1.5 months.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information has been requested and received stating that the patient's visual acuity was 0.5-0.6.The patient was not satisfied with the result.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC TRIFOCAL IOL
• Type of Device: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 17728565
• MDR Text Key: 323168437
• Report Number: 1119421-2023-01589
• Device Sequence Number: 1
• Product Code: MFK
• UDI-Device Identifier: 00380652390453
• UDI-Public: 00380652390453
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.165
• Device Lot Number: 15459413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL, CARTRIDGE D.; MONARCH III IOL, INJECTOR.; UNKNOWN VISCOELASTIC.; WAVELIGHT FS200 FEMTOSECOND LASER.
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male