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

Model Number	TFNT50
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.(b)(4).
Event or Problem Description
A healthcare professional reported that following a intraocular lens (iol) implantation procedure, the iol rotated.Iol rotation was performed and then rotated again a "few days" later.Iol rotation was performed and the lens rotated again for a third time.The iol was exchanged for the same model and power and the patient is well.Information was received indicating that the iol was exchanged with an alternate iol (same model and power) after the second rotation procedure.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.10.Evaluation summary: the lens was returned for evaluation.Solution is dried on the lens.The lens has been cut in half, typical of insertion and removal from the eye.Both halves are adhered to each other by solution.A split crack is observed on the edge of one of the pieces in the haptic optic junction.Light scratches are observed on the lens.Qualified associated products were indicated.The root cause for the reported events could not be determined.A malfunction has not been indicated or information provided that the lens was the cause of the event.The surgeon removed the lens and replaced with the same lens model and diopter.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
• MDR Report Key: 11656240
• Report Number: 1119421-2021-00815
• Device Sequence Number: 3511244
• Product Code: MFK
• UDI-Device Identifier: 00380652390996
• UDI-Public: 00380652390996
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 11/30/2023
• Device Model Number: TFNT50
• Device Catalogue Number: TFNT50.160
• Device Lot Number: 12671294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUOVISC; MONARCH IOL CARTRIDGE D; MONARCH IOL INJECTOR; DUOVISC; MONARCH IOL CARTRIDGE D; MONARCH IOL INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention