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	Foreign Body Sensation in Eye (1869); Headache (1880); Nerve Damage (1979); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/09/2022
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 consumer reported that following a cataract extraction with intraocular lens (iol) implant procedure, the patient experienced blurry, halos, flickers, astigmatism, irritation, weird flashes and sinus issue.Additional information was provided that the patient could also got mild posterior capsule opacification, foreign body sensation in conjunctival, trichiasis and was prescribed with antibiotics, he also got epilation, also had myopia, presbyopia, foggy vision, mild discomfort and soreness.No further information available.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
On the initial mdr missed to report b.5, information provided in b.5.And e.4 code was an error it should have been ¿yes¿ in the original mdr.Corrected information provided in e.4.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stated that customer satisfaction was lower, very vague visual flickering and the halos are permanent.Surgeon was unable to correct the problems.
Event or Problem Description
Additional information has been received stated that patient get ocular headaches from the nerve damage during the surgery and cannot safely drive after dark due to huge rosettes and starbursts.Patient still not able to drive at night after 8 months.Additional information has been received stated that after 9 months patient still have glare and had bad starbursts from lights that he cannot drive at night.No further information available.
Additional Manufacturer Narrative
Additional information provided in b.2., b.5., and h.6.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Each lens is subjected to a 100% assessment of the power (spherical and cylinder) and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received stated that patient still have astigmatism, glare, haloes and need strong readers and the lenses must be difficult to insert.Patient stated that the first three months were hellish and now patient have permanent daily headache behind the left eye.

• 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: 14247833
• Report Number: 1119421-2022-00888
• Device Sequence Number: 17254775
• Product Code: MFK
• UDI-Device Identifier: 00380652418560
• UDI-Public: 00380652418560
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/20/2022

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: TFAT30
• Device Catalogue Number: TFAT30.130
• Device Lot Number: 12752794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 05/02/2022; 06/21/2022; 08/27/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/26/2022; 07/15/2022; 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC VISCOELASTIC SYSTEM.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female