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

Model Number	TFNT00
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); Halo (2227)
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 physician reported after an intraocular lens implant procedure, small amount of refractive error and glare was observed, hence subsequent laser refractive surgery was performed.The patient is put into observation and may decide for an exchange if required.Additional information has been requested and received which states unable to drive at night with halos.There are two medical device reports associated with this event.This report is for the left eye.
Event or Problem Description
Additional information has been received stated that company lens was explanted and patient was implanted with non company lens for residual refractive error, vision was good but did not resolved the glare the surgeon explanted the non company iol for the company iol of different diopter.Additional information has been received stated that halos are better but near vision was decreased but ok with reading glasses.
Additional Manufacturer Narrative
In the initial mdr sulcoflex piggybank was reported in b.7.Inadvertently.Corrected information provided in d.10.The lens was returned in a specimen cup filled with a clear liquid.The lens had been cut into pieces, typical of insertion and removal.The product investigation could not identify a root cause for the reported complaint.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the surgeon implanted a piggy back lens with the 20(1.00cyl), 22.5 diopter (add power +2.2/+3.2) lens model in an attempt to correct the residual refractive error.The piggy back lens was explanted with the company lens.Additional information was provided that the multifocal company lens (1.00cyl), 22.5 diopter (add power +2.2/+3.2) lens was replaced with a monofocal company lens (2.25cyl), 24.0 diopter lens.Due to the difference in the cylinder power and an exchange of a multifocal lens to a 1.50 diopter higher, monofocal lens, this may suggest that the replacement lens model was an improved choice for the patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX 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: 15453554
• Report Number: 1119421-2022-02000
• Device Sequence Number: 7053083
• Product Code: MFK
• UDI-Device Identifier: 00380652357791
• UDI-Public: 00380652357791
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: TFNT00
• Device Catalogue Number: TFNT00.230
• Device Lot Number: 12759726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2019
• 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: SULCOFLEX PIGGYBACK IOL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown