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

Model Number ASKU

Device Problem Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

An other health care professional reported that during intraocular lens (iol) implantation procedure, a very small tear in the lens material was noticed.In the doctor's opinion it might be on the inside of the cartridge.Additional information was received.The doctor himself thinks that the tear in the lens material might be due to the inside of the cartridge.The lens remains inside the 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.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.

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).

• Brand Name: MONARCH IOL DELIVERY SYSTEM, CARTRIDGE
• 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: 18157050
• MDR Text Key: 328365756
• Report Number: 1119421-2023-01916
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2023

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
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACRYSOF IOL; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; UNSPECIFIED DELIVERY SYSTEM