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

Model Number	TFAT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-health care professional reported since the surgery was not able to achieve a 20/20 vision, and now have a permanent visual acuity disability that cannot be corrected and have blurry vision that is not correctable.This has nothing to do with the surgery itself.This is due to the lens that has resulted in permanent visual loss.It was further reported that already been treated with a yag laser.
Event or Problem Description
Additional information was received stating vision was good after yag.The lens was well centered and there was no retinal or glaucoma damage.
Additional Manufacturer Narrative
Additional information provided in b.5., b.6., b.7., and d.10.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating the vision has improved and the patient wears glasses.The vision corrected to 20/25 and this is where vision will remain.The patient was not hospitalized for the event.
Additional Manufacturer Narrative
Correction information provided in b.5., b.7., and d.10.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL
• Common Device Name: 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: 16254600
• Report Number: 1119421-2023-00208
• Device Sequence Number: 20146057
• Product Code: MFK
• UDI-Device Identifier: 00380652429696
• UDI-Public: 00380652429696
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2023

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: 09/10/2025
• Device Model Number: TFAT00
• Device Catalogue Number: TFAT00.190
• Device Lot Number: 15098780
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 02/06/2023; 03/08/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 03/03/2023; 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPANY FOLDING FORCEPS; ISTENTW; MONARCH II LOADING FORCEPS; MONARCH III IOL CARTRIDGE D; ORA SYSTEM; PROVISC
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male