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); Visual Disturbances (2140); Burning Sensation (2146); 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 experienced hazy vision at a distance, eye do not work together.Yag laser was performed but vision has not improved.Difficult to see to drive to see signs, driving at night is very difficult and there are shadows.The near vision was clear ad patient sent to retina specialist there were no signs of bleeding and retina is clear.Patient is unhappy with lens.Additional information was requested and received stating eyes are now burning too, both eyes feel sore and instructed to see a doctor or see a second opinion since this is not a normal symptom to feel and the last time she has seen her doctor was 2 weeks ago.There are two medical device reports associated with this patient.This report is associated with the left eye.
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 has been another complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in b.5.Corrected information was provided in h.6.In initial report the code was missed to submit 2146.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was requested and received stating patient not able to see past 23 feet, very depressed, doesn't feel safe.States was able to see better prior to surgery.

• 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: 14398613
• Report Number: 1119421-2022-01020
• Device Sequence Number: 14840874
• Product Code: MFK
• UDI-Device Identifier: 00380652419017
• UDI-Public: 00380652419017
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Followup
• Report Date (Section B): 09/02/2022

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: 10/31/2024
• Device Model Number: TFAT40
• Device Catalogue Number: TFAT40.090
• Device Lot Number: 12756666
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female