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 Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-health care professional reported following the intraocular lens implantation the patient has experienced visual impairment hence the lens was explanted.The clinical reason given for the explant was mechanical complication.Additional information has been requested and received stating there was no patient harm.The patient was not hospitalized for the event.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.10.The customer indicated the use of a qualified cartridge and handpiece.A viscoelastic was indicated which is not qualified for use with the lens/cartridge indicated.An lens exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.Based on the information provided, the event does not appear to be related to the product.Information was provided that the multifocal, company lens, 12.5 diopter (add power +2.2/+3.2) lens was replaced with a competitors, 16.0 diopter, monofocal lens model with reason visual impairment and a clinical reason mechanical complication.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: 13519091
• Report Number: 1119421-2022-00244
• Device Sequence Number: 11880538
• Product Code: MFK
• UDI-Device Identifier: 00380652392785
• UDI-Public: 00380652392785
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022

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: 06/12/2026
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.125
• Device Lot Number: 15214662
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 02/12/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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: B&L LI61A0 16.0; HEALON; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown