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 Scratched Material (3020)

Patient Problem Insufficient Information (4580)

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.A photo was provided of an implanted single-piece lens.A narrow scratch was observed on the anterior surface of the optic.The scratch appears to travel in from the optic/haptic junction into the optic center.The observed scratch was similar in appearance to damage caused by forceps.If the lens was loaded properly, the anterior surface would not contact the surface of the monarch cartridge.Damage to the anterior surface may be caused by forceps during loading or by a plunger override during advancement.The lens remains implanted.The manufacturer internal reference number is: 2023-76584.

Event Description

A physician reported that during intraocular lens (iol) implantation procedure, a scratch or tear was noticed on the lens.The scratch/tear seemed to be from the inside of the cartridge.The lens remains implanted in patient's eye.Additional information was received.The scratch was found on the anterior side of the optic.The lens folding went well.According to the reporter perhaps there was a very small burr or crystal on the forceps on the underside of the thin upper leg, (which touches the optic when pushing the iol down) that caused the scratch on lens.However, the scrub nurse could not yet explain this because the forceps were pulled back against the roof of the cartridge, so that this does not scrape the optics.The doctor indicated that the scratch was immediately visible when the iol was still unfolding in the eye, so immediately upon insertion.It seemed on the photos as if the scratch was always present on the trailing haptic, though it could not be entirely said, as the surgeon sometimes rotates the iol during the procedure.But for this case the scrub nurse indicated that she was sure that the surgeon no longer rotated the iol.The reporter also reported that the iol was sometimes loaded a little early, but had not seen that the dwell time was more that 3 minutes.According to the reporter the dwell time could not be an issue, because the haptics and iol were nicely folded and there was no stretched haptic.The customer had no idea what caused the incident, but speculated it might be the forceps.Everything went smoothly with the lens folding, procedure, and temperature.

• 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: 18237182
• MDR Text Key: 329368070
• Report Number: 1119421-2023-02053
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00380659777639
• UDI-Public: 00380659777639
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065977763
• Device Lot Number: 15683141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF IQ VIVITY EXTENDED VISION IOL.; MONARCH II LOADING FORCEPS.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 54 YR