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)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned for analysis.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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A administrator reported that following an intraocular lens (iol) implant procedure, the patient experienced poor quality vision.The lens was explanted in a secondary procedure after 10 months of initial implantation.The clinical reason for the explant was failure to neuro adapt.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned in a specimen cup.Solution was dried on the lens.One haptic was broken in the gusset area (not returned).The optic was torn/split/cracked (possibly cut) from edge past center of the lens.Power and resolution testing could not be conducted due to the extensive optic damage.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.Replacement lens information was not provided.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: 14989053
• Report Number: 1119421-2022-01522
• Device Sequence Number: 11233087
• Product Code: MFK
• UDI-Device Identifier: 00380652415057
• UDI-Public: 00380652415057
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 09/13/2022

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: 09/30/2024
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00U230
• Device Lot Number: 12748292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2019
• 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: MONARCH III CARTRIDGE D; MONARCH III INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female