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

Model Number	TFNT00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An ophthalmologist reported that the lens had line at the center of the optic.The scratch was observed after the lens was implanted into the eye.The lens remained in the eye and the surgery was completed.There was no harm to the patient.Additional information was requested.
Event or Problem Description
Additional information was requested, but no new information was received.
Additional Manufacturer Narrative
Two photos were provided of the lens in the eye.A line/mark can be observed across the central portion of the optic.Unable to visualize the haptics to determine the travel path of the mark.Associated products were not provided.It is unknown if qualified associated products were used.The lens remains implanted.Photos were provided and a line/mark was observed.The nature and cause of the observed line could not be determined from the photo.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 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: 12917702
• Report Number: 1119421-2021-02294
• Device Sequence Number: 12064025
• Product Code: MFK
• UDI-Device Identifier: 00380652357609
• UDI-Public: 00380652357609
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.135
• Device Lot Number: 12661838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/22/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• 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
• Patient Sex: Unknown