MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNWTT6
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	04/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that a thread-like substance was visible in the center of the lens after implantation and could not be removed even with irrigation aspiration.It is unknown whether it was a crack, a cortex, or a trace of bending.The surgery was completed by removing the lens and replacing it with another backup lens in an initial procedure.Additional information received stated that, no flare or endothelial damage were observed the next day and there is no problem currently.
Additional Manufacturer Narrative
Additional information was provided in h.3.The product was returned for analysis and the reported complaint was observed.Iol damaged and cut in half, solution is present on iol.Thread like foreign material is present on the iol.Sent to fw for further evaluation.The results from our particulate laboratory were as follows: microscopic examination shows numerous clear fibers up to 6.5mm in length adhered to the surface of the lens.The clear fibers were then isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the fibers¿ generated ir spectra to a library of spectra finds the best match to be texwipe fibers (natural fibers) (ft-ir spectra 1).We are unable to determine the root cause for the reported complaint "foreign material".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on the iol.The product was subject to handling as the reported damage was highlighted post implantation.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens condition would not meet our current release criteria.Based on the spectral comparison results, the fibre is texwipe fibers (natural fibers).This a commonly used material , including in medical products/environments.The origin of the material could not be determined.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16991918
• Report Number: 9612169-2023-00384
• Device Sequence Number: 17888529
• Product Code: MJP
• UDI-Device Identifier: 00380652470100
• UDI-Public: 00380652470100
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• 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): 09/26/2023

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: 06/08/2026
• Device Model Number: CNWTT6
• Device Catalogue Number: CNWTT6.190
• Device Lot Number: 25429234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2022
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR.; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; OVD: OPEGAN HI.
• Patient Sex: Unknown