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

Model Number	TFAT00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Visual Impairment (2138); Visual Disturbances (2140)
Date of Event	07/31/2023
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that, after intraocular lens implantation surgery, the patient has not noticed any improvement with vision.Hence the lens was removed and replaced with another lens in a secondary procedure.The clinical reason for explant was fuch's corneal dystrophy.Additional information was received stating that, in the surgeon's opinion the quality issue with the lens did not cause the event but the intermittent floaters was the cause of the event.There was no patient harm, and the prognosis of the patient was good.
Additional Manufacturer Narrative
The explanted lens was returned adhered to the underside of the lid for the non-company replacement lens model.Solution was dried on the lens.The optic was cut into pieces.Each lens was 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.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and handpiece were used.A non-qualified viscoelastic was indicated.Based on information provided by the customer, the root cause appears to be related to patient condition and unrelated to the product.The initial report description indicated that the lens was explanted with patient reason that he has not noticed improvement with vision.The clinical reason for the complaint is the patient's history of fuch's corneal dystrophy.The explanted lens was returned in pieces.The power and resolution of the returned lens could not be re-evaluated due to the optic damage.The 21.0 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced with a non-company monofocal 21 diopter lens.This information of the exchange from a multifocal lens to a monofocal lens further supports the root cause.Also noted was the use of a non-qualified viscoelastic.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX 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: 17734765
• Report Number: 1119421-2023-01594
• Device Sequence Number: 6440529
• Product Code: MFK
• UDI-Device Identifier: 00380652429733
• UDI-Public: 00380652429733
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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: TFAT00
• Device Catalogue Number: TFAT00.210
• Device Lot Number: 15463012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/12/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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: HEALON.; MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.; MX60E+21.0 SN:(B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male