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

Model Number	TFNT40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Hemorrhage/Blood Loss/Bleeding (1888); Blurred Vision (2137); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following a cataract extraction with intraocular lens (iol) implant procedure, a patient complained that she had a difficulty seeing.(b)(6) was not good, but it wasn't that bad.However, it got worse after that.The patient complained that she had difficulty seeing as if it had a spider web.The patient has diabetes mellitus and mild fundus hemorrhage, but no retinal abnormalities such as vitreous opacity or edema.She also has dry eye, but she is continuing eye drop treatment and it has not got worse much.Her (b)(6) improved when another doctor put contact lenses during postoperative procedures.Posterior capsulotomy by yag laser was performed.Additional information was requested.
Additional Manufacturer Narrative
The product was not returned for analysis.A qualified cartridge was indicated.A non-qualified handpiece was used with the qualified lens/cartridge combination.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the account for further investigation.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TORIC 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 ; 8175514979
• MDR Report Key: 12584689
• Report Number: 1119421-2021-01900
• Device Sequence Number: 3376010
• Product Code: MFK
• UDI-Device Identifier: 00380652390439
• UDI-Public: 00380652390439
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2021

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: TFNT40
• Device Catalogue Number: TFNT40.155
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: AE-9063CSP; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; AE-9063CSP; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Female