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

Model Number	TFNT00
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, there was defect in center of lens.The lens was removed and second spare lens used to complete the procedure.There was no patient harm.Additional information was received, when the lens was inserted doctor observed a defect which he said was from the way the lens had been folded.The patient has been seen post operatively and was due for a further check up in four weeks time.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.The product was not returned.Two photos and a video were provided.The first photo and the video show a computer monitor displaying an image of the lens in the eye.The image is blurry and there is a lot of light reflection on the monitor.A dark line can be seen near the center of the lens.Possibly a crack.Due to the quality of the image, a determination cannot be made.The second photo shows the lens adhered to the lens case.Viscoelastic can be seen on the lens.One haptic is broken in the gusset area.A dark line can be seen near the center of the lens.Possibly a crack.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a qualified associated cartridge with an unspecified handpiece and non-qualified viscoelastic.The account indicated the product was not available to evaluate.The clarity of the provided images did not allow for a confirmation of the reported damage.A dark like was observed, which may be a crack.It is difficult to make a final determination without evaluation of the physical sample.The root cause for the reported damage may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was indicated.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.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: 20840824
• Report Number: 1119421-2024-02371
• Device Sequence Number: 3730132
• Product Code: MFK
• UDI-Device Identifier: 00380652357777
• UDI-Public: (01)00380652357777(17)280509(11)230512(10)15639658
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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 Model Number: TFNT00
• Device Catalogue Number: TFNT00.220
• Device Lot Number: 15639658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/13/2025
• Date Device Manufactured: 05/12/2023
• 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: MONARCH III IOL, CARTRIDGE D; NUVISC VISCOELASTIC; UNSPECIFIED INJECTOR
• Patient Age: 78 YR
• Patient Sex: Female