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

Model Number	TFAT30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Headache (1880); Inflammation (1932); Blurred Vision (2137); Visual Disturbances (2140); Depression (2361); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following implantation of an intraocular lens (iol) the patient faced difficulties not sure if it is due to the lenses and might be an allergic reaction to the lens material.The patient symptoms are burning and stabbing pain, headaches from eye strain, wavy and blurry vision, feels like sand is in her eyes, has to wear sunglasses because of light sensitivity, and this has all affected her quality of life and as caused depression.Patient has tried drops and ointments which have caused more pain and believes patient is allergic to the preservatives in those products.The doctor switched her to xiidra, but it's not helping.The patient has blepharitis.There are two medical device reports associated with this patient.This report is associated with the right eye.Additional information was requested and received.
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).

• 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: 14672887
• Report Number: 1119421-2022-01245
• Device Sequence Number: 5502939
• Product Code: MFK
• UDI-Device Identifier: 00380652418607
• UDI-Public: 00380652418607
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2022

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: 01/10/2026
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.150
• Device Lot Number: 15127895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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: MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female