MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; INTRAOCULAR LENS

Model Number	DAT415
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A doctor reported that during an intraocular lens (iol) implant procedure, the filament was removed from the posterior of the lens, on the optic just inferior to the haptic optic junction.Additional information was requested.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.10.The lens was not returned.A lens case base was returned with information that the particle was adhered to it.The lens case and the bag it was in were sent to the particle lab.Lab results: the sample was visually and microscopically examined.A foreign material was observed on the rim of the lens case.A loose fiber was also found in the bag the case was returned in.No material that matched the description of a ¿filament¿ was found.A clear material was observed on the returned lens case and a fiber was found in the bag.The clear material on the lens case and the fiber from the bag were isolated and isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).The clear material on the lens case yielded no good matches.Comparison of the fiber's generated spectra to a library of spectra found the best match to be texwipe fibers (natural fibers).The clear material on the lens was then isolated and analyzed using the hitachi scanning electron microscope (sem) equipped with an edax energy dispersive x-ray spectrometer (eds).The eds of the sample identified sodium (na), chlorine (cl) and potassium (k).These elements along with the visual characteristics suggest the material is dried salt.Possibly from dried bss.The returned used company cartridge was evaluated.Inadequate viscoelastic was observed in the cartridge.No cartridge damage was observed.The cartridge had evidenced of placement into a handpiece.The used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.The returned cartridge is qualified with the reported lens model/diopter.The handpiece and viscoelastic used were not provide it is unknown if qualified products were used.The root cause for the reported foreign material could not be determined.The lens was not returned.The returned lens case and bag were evaluated.No material that matched the description of a ¿filament¿ was found.The fiber from the bag was analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the fibers generated spectra to a library of spectra found the best match to be texwipe fibers (natural fibers).The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 15674160
• Report Number: 1119421-2022-02270
• Device Sequence Number: 6348599
• Product Code: POE
• UDI-Device Identifier: 00380652427920
• UDI-Public: 00380652427920
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P930014
• 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): 01/13/2023

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: 05/18/2026
• Device Model Number: DAT415
• Device Lot Number: 15205694
• 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: 09/28/2022
• Supplement Date Received by Manufacturer: 12/17/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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: CUSTOM-PAK; MONARCH III IOL
• Patient Sex: Unknown