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

Model Number	TFAT40
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 and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.No other complaints in the lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient¿s vision was decreased and causing trouble with daily activities due to surgically induced astigmatism.The iol was exchanged with an alternate iol, 286 days following the initial procedure.Additional information has been requested; however, further information has not been received.
Additional Manufacturer Narrative
The customer indicated, the use of a qualified company cartridge and company handpiece.The customer indicated, the use of a viscoelastic.Which is not qualified for company cartridge use.The product investigation could not identify, a root cause for the reported complaint.The product was not returned to evaluate.No additional information has been provided at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 12752875
• Report Number: 1119421-2021-02065
• Device Sequence Number: 1441968
• Product Code: MFK
• UDI-Device Identifier: 00380652419307
• UDI-Public: 00380652419307
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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: 03/08/2025
• Device Model Number: TFAT40
• Device Catalogue Number: TFAT40.235
• Device Lot Number: 15053673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2020
• 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: ACRYSOF TRIFOCAL IOL; AMVISC PLUS; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; ACRYSOF TRIFOCAL IOL; AMVISC PLUS; MONARCH III CARTRIDGE D; MONARCH III INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Female