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

Model Number	TFAT50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	02/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported following an intraocular lens implant procedure, the patient experienced blurred visual acuity and refractive error.The lens was later exchanged in a secondary procedure.No patient harm noticed.Additional information has been requested.
Additional Manufacturer Narrative
The explanted lens was returned in a plastic specimen jar with a screw top lid.Solution was dried on the lens.Scratch damage was observed at one haptic/optic junction.The other haptic/optic junction was cracked.Cracked areas were also observed on the anterior and posterior optic surface in the location of the rings.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.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified cartridge and handpiece were indicated.A non-qualified viscoelastic was indicated.There have been no other complaints reported in the lot number.The root cause was determined to be unrelated to the lens.Information was provided by the surgical site, that in the surgeon¿s opinion, the lens did not cause or contribute to the event.In the surgeon¿s opinion, preoperative measurements were the root cause for the event.Also the file indicated the exchange of a multifocal toric lens 27.5 diopter (+3.25 d near and +2.17 d intermediate add power) to a non-company, monofocal, non-toric lens 27.5 diopter.This information may also 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 TORIC 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: 14082610
• Report Number: 1119421-2022-00719
• Device Sequence Number: 5277558
• Product Code: MFK
• UDI-Device Identifier: 00380652419918
• UDI-Public: 00380652419918
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2022

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: TFAT50
• Device Catalogue Number: TFAT50.275
• Device Lot Number: 12736079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2019
• 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 IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; NUVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Unknown