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

Model Number	TFNT40
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.A photo was provided of the eye.The lens it not visible.There is an area observed in the center of the pupil, which may be the reported mark.This may be lens damage.Unable to make a determination from the provided photo.The manufacturer internal reference number is: 2022-57040.
Event or Problem Description
An optician reported that following a cataract extraction with an intraocular lens (iol) implant procedure, during patient¿s review after 5 days of implantation, a white demarcation line has been observed on the iol optic under slit lamp examination.Patient¿s vision was 6/7.5 and did notice a white line subjectively as well.Doctor planned to explant this iol and to re-implant a new lens for this patient.No patient harm was reported.Additional information was received stating the lens was exchanged with a same model in a secondary procedure.

• 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 ; 8007579780
• MDR Report Key: 15563000
• Report Number: 1119421-2022-02134
• Device Sequence Number: 17786009
• Product Code: MFK
• UDI-Device Identifier: 00380652390354
• UDI-Public: 00380652390354
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2022

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 Expiration Date: 06/01/2026
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.115
• Device Lot Number: 15211584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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: ALCON CANNULA OPHTHALMIC; MONARCH III IOL, CARTRIDGE D; MONARCH III IOL, INJECTOR; VISCOAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown