MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Catalog Number 8065977763

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2023

Event Type  Injury  

Manufacturer Narrative

The used company cartridge was returned.Viscoelastic was observed in the cartridge.The viscoelastic was still "wet".This is atypical of viscoelastic; unknown if it was diluted before use.No cartridge damage was observed.No foreign material was observed.The cartridge had evidence of placement into a handpiece.The returned used company cartridge was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.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 lens model/diopter 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 instructions for use (ifu) instructs that an 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 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• 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: 18074549
• MDR Text Key: 327420034
• Report Number: 1119421-2023-01873
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: 15598877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female