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

Model Number	DFT315
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was not returned for evaluation.A video was provided on a usb drive.The video does not show the lens and cartridge preparation or the lens delivery.The video starts with the lens already implanted in the eye.One haptic tip can be observed over the optic.The distal tip of the haptic appears to be scraped on the anterior surface.No ¿foreign material¿ was removed.The haptic unfolds and is no longer visible.The video ends.The provided photo appears to have been take from the video.The haptic was visible across the optic.The distal haptic tip appeared to be damaged.If the haptic was scraped, the removed material could have been interpreted as the reported foreign material.The company lens material can appear white when damaged.Unable to verify without physical evaluation of the lens.Product history records were reviewed and documentation indicated the product met release criteria.A qualified cartridge and viscoelastic were indicated.The handpiece used was not provided.It is unknown if a qualified handpiece was used.The root cause could not be determined for the observed haptic damage.Based on review of the provided video and photo the haptic tip appeared to have been scraped on the anterior surface.The haptic damage may have been interpreted as the reported foreign material.Company lens material can appear white when damaged.The lens remains implanted.It is unknown if a qualified handpiece was used.The instruction for use (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).
Event or Problem Description
A physician reported that during intraocular lens (iol) implantation, as the lens came out of the injector within the anterior chamber, it was noticed that the leading haptic edge had brittle white foreign matter coating along it whilst folded, which could possibly be lens glide matter.Additional information was received.The material looked like white sticky particles like snow.The physician stated that it might be the lens glide matter that is sometimes added to the inside of the cartridges which could have changed color for some reason.It looked like it got scraped out from within the cartridge.It was definitely foreign matter and nothing that was ever seen before and nothing from the tray.At the one week visit the patient was fine.No infection.The physician tried to rub it off with irrigation/aspiration (i/a) but at least 50% was stuck too firmly and couldn¿t be removed.The looser stuff was able to be aspirated.

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION 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: 18074603
• Report Number: 1119421-2023-01874
• Device Sequence Number: 18058729
• Product Code: POE
• UDI-Device Identifier: 00380652421652
• UDI-Public: 00380652421652
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2026
• Device Model Number: DFT315
• Device Lot Number: 15213704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female