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

Model Number	TFNT50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned to the manufacturing site.Complaint 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
A physician reported that following an intraocular lens (iol) implant procedure the patient eye sight did not improved.The iol was exchanged in a secondary procedure with another lens.The patient was resolved from the events.
Additional Manufacturer Narrative
The lens was returned wrapped in surgical gauzes.Solution was dried on the lens.One haptic was broken/cut haptic (not returned).The optic was cut into pieces.The damage observed is typical of insertion and removal.Power and resolution testing could not be conducted due to the extensive optic damage.Associated products were not provided.It is unknown if qualified products were used.The root cause for the reported event could not be determined.The specific issue with the lens was not provided.A malfunction has not been indicated.The power and resolution of each lens is 100% evaluated during the manufacturing process to determine acceptability per model and diopter.The manufacturer internal reference number is: 2021-41384.

• 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
• MDR Report Key: 12195376
• Report Number: 1119421-2021-01405
• Device Sequence Number: 19205955
• Product Code: MFK
• UDI-Device Identifier: 00380652390965
• UDI-Public: 00380652390965
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2021

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 Expiration Date: 11/30/2023
• Device Model Number: TFNT50
• Device Catalogue Number: TFNT50.145
• Device Lot Number: 12673530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention