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

Model Number	TFNT40
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Nausea (1970); Visual Disturbances (2140); Vomiting (2144); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported that following an intraocular lens (iol) implant procedure, the patient experienced vomiting, patient could not stand up, weak and very nauseous.The patients pupil was enlarged.Additional information has been received and stated that, patient visited surgeon post operation 1 day and surgeon stated that , he left too much ''glue'' or ''goo'' in her eye that's what caused her eye pressure to go so high.Surgeon put her on drops to lower pressure after he released some of it manually.The patient had used the cholinergic agonist eye drops to decrease the size of pupil.The size was decrease but still did not com to the normal.Additional information received from the consumer and stated that she sees fog was the lens being out of whack.The surgeon told to consumer that, the iol was tilted and not lying flat in the eye.The surgeon stated that, which was probably by the intraocular pressure.The surgeon had done the repositioning of iol and also told me that new lens would put if warranted.
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).
Additional Manufacturer Narrative
The product investigation could not identify a root cause for the reported complaint.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.All information has been reported by the patient.Reported 1 day post op surgeon indicated the eye was not flushed enough, which caused the high eye pressure issue.Surgeon prescribed drops to lower pressure after releasing some liquid manually.Pupil is smaller, but still somewhat dilated despite the prescribed drops.Patient stated the surgeon indicated the lens was tilted.Information was provided that repositioning surgery done on (b)(6) 2021.Patient is waiting on consultation results for future plan.File will be reopened when new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, the physician stated that due to an astigmatism, her pupil is irregular and the lens in pulling towards the side with the spring.Scar tissue has started forming.The lens was over the membrane at the bottom, and under the membrane at the top.The consumer consulted with another physician and physician tried a hard contact lens on my eye to determine if it was a cornea issue.The physician tried the lens, and he determined the issue was not the cornea, and that even with the hard lens.The patient vision was only 20/50, which it is without the contact.The consumer is waiting for the surgeons opinion.
Additional Manufacturer Narrative
Additional information provided.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, the symptoms are still continuing.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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: 13087797
• Report Number: 1119421-2021-02469
• Device Sequence Number: 14886771
• Product Code: MFK
• UDI-Device Identifier: 00380652416078
• UDI-Public: 00380652416078
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2022

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: 07/31/2024
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40U210
• Device Lot Number: 12735962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 02/28/2022; 04/08/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 03/23/2022; 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2019
• 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: ACETAZOLAMIDE.; OFLOXACIN.; PREDNISONE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female