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

Model Number	TFNT00
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	11/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint 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 physician reported that following the intraocular lens implant procedure, iol found to have spot in the center of the optic.Iol remained implanted.Additional information has been received and stated that, the iol was explanted in a secondary procedure.
Additional Manufacturer Narrative
A photo was provided of the eye.Rings are visible indicating a multifocal iol.Large areas are observed in the center that have the appearance of scrape marks.It cannot be verified to be damage from the photo.A viscoelastic was indicated that is qualified when used with a qualified cartridge and handpiece combination.The cartridge and handpiece information was not provided.The indicated active sentry is a company cataract hp tool used in the removal of the cataract from the eye.The product investigation could not identify a root cause for the reported complaint.The explanted lens was not returned for an evaluation.The complaint was for "a spot in the center of the optics".A photo was provided.Based on our observation of the attached photo, the photo displayed what may be scrape marks.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.The file indicated that no sample was expected.Multiple follow ups were conducted.The lens was explanted (b)(6) 2022.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: 15903188
• Report Number: 1119421-2022-02543
• Device Sequence Number: 17651017
• Product Code: MFK
• UDI-Device Identifier: 00380652357784
• UDI-Public: 00380652357784
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.225
• Device Lot Number: 15351500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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: CENTURION ACTIVE SENTRY HANDPIECE; DUOVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown