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

Model Number	TFNT40
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Codes	Blurred Vision (2137); Insufficient Information (4580)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A non health care profession reported that, during the iol implant procedure lens found to be with deposit, which also does not go away with administration of steroid.It doesn't seem to be the capsule.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
A photo was provided and reviewed by a director with global quality customer affairs.The results of the photo review were: one slit lamp image was provided and reviewed of a reported ¿deposit¿ on the lens with a request if this appearance is recognized.The image shows off-axis illumination of a dilated pupil with the rings of the optic features of the reported compkany lens present.There is a large refractile area in the lens where it is difficult to determine depth based on the photo.If the affected area is near the posterior surface, wrinkles in the capsule may be a possibility, otherwise the image does not appear consistent with any obvious recognized appearance.Information was provided that indicated the use of a qualified cartridge and viscoelastic.The associated handpiece information was not provided.No sample was returned.Based on a summary of the provided slit-lamp photo review, the image shows off axis illumination of a dilated pupil.A large refractile area is shown in the lens where it is difficult to determine depth based on the photo.If the affected area is near the posterior surface, wrinkles in the capsule may be a possibility, otherwise the image does not appear consistent with any obvious recognized appearance.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.The manufacturer internal reference number is: 2023-09837.
Event or Problem Description
Additional information received and stated that, deposit remained constant, the patient had lesser vision.
Event or Problem Description
Additional information received and stated that, the lens is still inside the patient eye and no explantation took place.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received and stated that, lens with the deposit has been explanted in a secondary procedure.Surgery has been completed with a new lens.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned in the well area of the replacement lens case.Blood and viscoelastic were observed on the lens.The lens had been cut into two pieces across the center.One portion was cracked on a post of the lens case due to the returned lens position.The lens was cleaned with klrp for further evaluation.No material abnormalities or deposits were observed.Loose material was found along the cut edge of one optic portion, which had similar location and appearance to the pictured material.The material was removed and isolated between glass slides and sent to the particle lab.One slit lamp image was provided.The image showed off-axis illumination of a dilated pupil with the rings of the optic features of the reported panoptix lens present.There was a large refractile area in the lens where it was difficult to determine depth based on the photo.If the affected area was near the posterior surface, wrinkles in the capsule may be a possibility, otherwise the image does not appear consistent with any obvious recognized appearance.The material found on the lens was removed and isolated between glass slides and sent to the particle lab.Lab results: the sample was visually and microscopically examined, and the reported foreign material was observed.Microscopic examination shows numerous pieces of clear material up to 2.3mm in length adhered to the glass slide.The clear material was then isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the material¿s generated ir spectra to a library of spectra finds the best match to be protein.This would indicate the material was organic in nature and would be unrelated to the lens or the cartridge.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge and viscoelastic.The associated handpiece information was not provided.The root cause for the reported "deposit" could not be determined.No material abnormalities or deposits were observed.Loose material was found along the cut edge of one optic portion, which had similar location and appearance to the pictured material.However, we cannot conclusively verify this was the pictured material.One slit lamp image was provided.The image showed off-axis illumination of a dilated pupil with the rings of the optic features of the reported company lens present.There was a large refractile area in the lens where it was difficult to determine depth based on the photo.If the affected area was near the posterior surface, wrinkles in the capsule may be a possibility, otherwise the image does not appear consistent with any obvious recognized appearance.The material was removed from the lens portion, isolated between glass slides and sent to the particle lab.Lab results: microscopic examination showed numerous pieces of clear material up to 2.3mm in length adhered to the glass slide.The clear material was then isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the material¿s generated ir spectra to a library of spectra finds the best match to be protein.This would indicate the material was organic in nature and would be unrelated to the lens or the cartridge.Information was provided that the company, 21.5 diopter lens was replaced with a company, 22.0 diopter lens.The change in spherical power may indicate the replacement lens was a better choice for the patient's visual needs.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: 16511458
• Report Number: 1119421-2023-00418
• Device Sequence Number: 6786950
• Product Code: MFK
• UDI-Device Identifier: 00380652390552
• UDI-Public: 00380652390552
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TFNT40
• Device Catalogue Number: TFNT40.215
• Device Lot Number: 15437023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 03/22/2023; 04/24/2023; 06/01/2023; 12/07/2023; 03/29/2024
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/18/2023; 05/19/2023; 06/26/2023; 01/01/2024; 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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: MONARCH CARTRIDGE D.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male