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

Model Number ASKU

Device Problems Defective Device (2588); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 08/15/2023

Event Type  malfunction  

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).

Event Description

A physician reported that during an intraocular lens (iol) implant procedure, when injecting the lens, they felt some resistance at some point.The lens looked like it was getting scrunched in the barrel when advancing, so they stopped.The lens was half in, half out, but could see that the optic was cut on both sides (about 90 degrees from the haptics) most of the way.Physician mentioned if they had continued advancing, it would have surely completely been cut in half.They removed that iol and put in a new unspecified iol.When looked at the cartridge that had been used, it was clearly abnormal on the back surface.There was a plastic shred sticking out, and the back surface had what might be a crack or something.Physician mentioned the only way they did not noticed it as there was a lot of company viscoelastic coming out the front that somehow obscured view of it.Additional information has been requested.

• 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: 17736959
• MDR Text Key: 323283262
• Report Number: 1119421-2023-01599
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P063155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2023

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
• 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: 08/17/2023
• Initial Date FDA Received: 09/13/2023
• 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: IOL, UNSPECIFIED; MONARCH IOL INJECTOR, UNSPECIFIED; VISCOAT