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

Model Number	TFNT40
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A ophthalmologist reported that during intraocular lens (iol) implantation procedure, a strand was found attached to the lens in the patient's eye.The strand was removed from the eye in same procedure.There was no patient harm.The lens remains implanted in patient's eye.
Additional Manufacturer Narrative
A sample device was not returned for analysis.The lens remains implanted.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.A clear bandage was returned taped to a piece of paper.The bandage had marker on it.Inside the bandage was a long, fiber.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information provided in h.3.And h.10.The lens and the cartridge were not returned for evaluation.A clear bandage was returned taped to a piece of paper.The bandage had marker on it.Inside the bandage was a long, blue fiber.The fiber was sent to the particle lab for evaluation.The reported foreign material was observed.Microscopic examination shows a blue fiber approximately 12mm in length.The blue fiber was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the fiber¿s generated ir spectra to a library of spectra finds the best match to be polypropylene.Qualified associated products were indicated.The root cause for the reported "strand" could not be determined.The reported "strand" was returned.The "strand was a long blue fiber.Although polypropylene is used in the intraocular lens (iol) lens case and the company cartridge (white/clear).No blue fiber polypropylene material is used at the manufacturing site.The origin of the long blue fiber cannot be determined.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
• 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: 17029267
• Report Number: 1119421-2023-01005
• Device Sequence Number: 17869675
• Product Code: MFK
• UDI-Device Identifier: 00380652390613
• UDI-Public: 00380652390613
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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: 08/12/2025
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.245
• Device Lot Number: 15091408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/06/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 08/14/2023
• Date Device Manufactured: 08/13/2020
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown