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	Headache (1880); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Hyporesponsive to stimuli (2683); Eye Pain (4467)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that following a cataract extraction with an intraocular lens (iol) implant procedure, patient experienced halos which obliterated her early evening and night vision.The halos were so big taking over the entire road.She could not see to safely make turns.Though after waiting the appropriate settle-in time suggested by her doctor, halos did not go away.Her eyes felt like they were under water all the time.Additional information was received stating she experienced halos front the start, things felt blurrier and her depth perception was off.The low contrast was disconcerting when driving and she had to buy several pairs of different sunglasses to help provide more contrast.Low light indoors was not good.She had tumbled off a staircase twice because she could not see the last step.She was so disappointed with the outcome of her surgeries.She was hoping that the halos will go away.She was not being able to drive home at night.The halos obliterate the view on the road in the distance growing larger and larger as vehicles get closer.The area of the halo was larger than that of the car, reaching above, below and left and right sides, spilling into her traffic lane.She could not see where to make a left hand turn because of this.The low contrast aspect made the road directly in front of her disappear.Patient experienced headache, tired, eye achy for bright light.First thing in the morning was not so good and if she woke up in the night and pick up a book, its blurry, not blurry like before the surgery, but she put on glasses for bit.Some indoor lights bother her, when she saw sunny windows from inside, she could not reset her eyes there and have to avert.If she move too fast she feel off balance.Her night vision was awful, worse than before surgery.The halos around the lights were terrible.Car headlights, tail lights, blinkers, street lights, traffic lights have huge halos in concentric circles.When in traffic, the distance was obliterated by the glare and size of the halos.She was having difficulty seeing in the distance.She bought two different kind of polarized glasses to see if they would help.There are two medical device reports associated with this patient.This report is associated with the left eye.
Additional Manufacturer Narrative
Additional information was provided in b.6, d.10.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3, h.6 and h.10.The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause.The file will be reopened if additional information is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stated that there was no improvement in the quality of vision.The lens was explanted and replaced with non-company lens in a secondary procedure.

• 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: 15735063
• Report Number: 1119421-2022-02358
• Device Sequence Number: 14167923
• Product Code: MFK
• UDI-Device Identifier: 00380652418713
• UDI-Public: 00380652418713
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/14/2023

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 Model Number: TFAT30
• Device Catalogue Number: TFAT30.205
• Device Lot Number: 15335137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 11/10/2022; 12/14/2022; 05/19/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/05/2022; 01/10/2023; 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• 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; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female